Powered Laser Surgical Instrument
FDA product code GEX · Class II (moderate risk) · 21 CFR 878.4810 · General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
2,880510(k) clearances
0PMA approvals
193recalls
Manufacturers
- Cynosure, Inc. 84
- Sharplan Lasers, Inc. 66
- Lumenis, Inc. 60
- Quanta System Spa 57
- Candela Corp. 53
- Laserscope 49
- Trimedyne, Inc. 48
- Heraeus Lasersonics, Inc. 37
- Surgical Laser Technologies, Inc. 35
- Pfizer Laser Systems 30
- Biolitec, Inc. 28
- New Star Lasers, Inc. 27
- Asclepion Laser Technologies GmbH 27
- Xintec Corporation 27
- Ceram Optec, Inc. 27
- Dornier Medtech America, Inc. 25
- Fotona D.D. 25
- Biolase Technology, Inc. 24
- Directed Energy, Inc. 24
- Nidek, Inc. 23
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 07/21/2026SE |
| K261693 | Diode laser hair removal machine (QDTM-04)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 07/17/2026SE |
| K261674 | Skin Air Cooling System (QALF-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 07/16/2026SE |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)GEX · Special | Micro-Energy Medical Technology Co., Ltd. | 06/18/2026SE |
| K261570 | Picosure WorkstationGEX · Special | Cynosure, LLC | 06/17/2026SE |
| K260690 | LumiGlam Laser System (SHE-LSP601-3)GEX · Traditional | Beijing Sano Laser S&T Development Co.,Ltd | 06/04/2026SE |
| K260489 | LASEmaR 1500GEX · Traditional | Eufoton S.R.L. | 05/29/2026SE |
| K260138 | LUNE PureHygieneGEX · Traditional | Enamel Pure | 05/29/2026SE |
| K253245 | Boston 2910 (Boston 2910)GEX · Traditional | Boston Aesthetics, Inc. | 05/21/2026SE |
| K260100 | MOSES RaydarGEX · Traditional | Boston Scientific Corporation | 05/18/2026SE |
| K261214 | Pico Shining (Pico-K; Picofy)GEX · Special | Speclipse, Inc. | 05/11/2026SE |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II)GEX · Traditional | Nanjing Bestview Laser S&T Co., Ltd. | 05/07/2026SE |
| K260256 | Q-Switched Nd: YAG Laser SystemsGEX · Traditional | Shanghai Apolo Medical Technology Co., Ltd. | 05/04/2026SE |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece:…GEX · Traditional | Leaseir Technologies, Slu | 05/04/2026SE |
| K261094 | YellowStarGEX · Special | Asclepion Laser Technologies GmbH | 04/29/2026SE |
| K253765 | Vanish ProGEX · Traditional | Ddc Technologies, Inc. | 04/22/2026SE |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q)GEX · Traditional | Nanjing Bestview Laser S&T Co., Ltd. | 04/20/2026SE |
| K260307 | Diode Laser Therapy Systems (V19)GEX · Traditional | Weifang Mingliang Electronics Co., Ltd. | 04/15/2026SE |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298)GEX · Traditional | Shanghai Apolo Medical Technology Co., Ltd. | 04/09/2026SE |
| K260375 | Nd: YAG Laser Therapy SystemsGEX · Traditional | Sanhe Meditech Co., Ltd. | 03/31/2026SE |
| K260257 | CO2 Laser SystemGEX · Traditional | Sanhe Meditech Co., Ltd. | 03/28/2026SE |
| K260632 | Laser Thermal Therapy KitGEX · Special | Elesta S.P.A | 03/17/2026SE |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | C.R. Bard, Inc. | 03/17/2026SE |
| K254197 | Picasso Pro Diode Laser (002-00460)GEX · Traditional | CAO Group, Inc. | 03/11/2026SE |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…GEX · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/06/2026SE |
| K253920 | CO2 Laser Treatment Machine (CFR3M1)GEX · Traditional | Haidari Beauty Technology (Beijing) Co., Ltd. | 03/03/2026SE |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)GEX · Traditional | Beijing HuaCheng Taike Technology Co., Ltd. | 02/27/2026SE |
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)GEX · Traditional | Beijing HuaCheng Taike Technology Co., Ltd. | 02/27/2026SE |
| K254271 | CapriGEX · Traditional | ORO Co., Ltd. | 02/26/2026SE |
| K252599 | Diode Laser Therapy Systems (WLA-02)GEX · Traditional | Wingderm Electro-Optics , Ltd. | 02/24/2026SE |
| K252561 | BTL-754FFGEX · Traditional | BTL Industries, Inc. | 02/18/2026SE |
| K252048 | 808nm semiconductor laser hair removal machineGEX · Traditional | Xi'An Taibo Electronic Technology Co., Ltd. | 02/03/2026SE |
| K251981 | Boston PICO (Boston PICO)GEX · Traditional | Boston Aesthetics, Inc. | 01/30/2026SE |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40)GEX · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 01/24/2026SE |
| K252753 | Vydence Family of LasersGEX · Traditional | Vydence Medical Industria E Commercio Ltda | 01/24/2026SE |
| K252369 | Boston Pico755GEX · Traditional | Boston Aesthetics, Inc. | 01/21/2026SE |
| K253342 | Pico-KGEX · Traditional | Speclipse, Inc. | 12/24/2025SE |
| K252877 | SANDRO DualGEX · Traditional | Wontech Co., Ltd. | 12/19/2025SE |
| K251077 | JOULE 1064nm System and AccessoriesGEX · Traditional | Sciton, Inc | 12/19/2025SE |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U)GEX · Traditional | Sanhe Lefis Electronics Co., Ltd. | 12/19/2025SE |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Nov…GEX · Traditional | Micro-Energy Medical Technology Co., Ltd. | 12/12/2025SE |
| K252658 | Medical Diode Laser Systems (TR-B)GEX · Traditional | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 11/28/2025SE |
| K253344 | Bellus-QGEX · Traditional | Speclipse, Inc. | 11/25/2025SE |
| K253219 | LeafPure-Echo (LM-LPNdA)GEX · Traditional | Shenzhen Leaflife Technology Co., Ltd. | 11/25/2025SE |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)GEX · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 11/24/2025SE |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…GEX · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 11/24/2025SE |
| K253123 | CuRAS hybridGEX · Traditional | Classys, Inc. | 11/20/2025SE |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…GEX · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 11/20/2025SE |
| K252564 | Medical Diode Laser Systems (VeinCure)GEX · Traditional | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 11/07/2025SE |
| K252519 | CO2 Laser Therapy System (K106)GEX · Traditional | Hebei Keylaser Sci-Tech Co.,Ltd | 11/07/2025SE |
| K252515 | Q-Switched Nd:Yag laser (K690)GEX · Traditional | Hebei Keylaser Sci-Tech Co.,Ltd | 11/06/2025SE |
| K251303 | Tamburo Thulium Fiber Laser SystemGEX · Traditional | Menovex Medical Technology (Shenzhen) Co., Ltd. | 11/04/2025SE |
| K252427 | Diode Laser Hair Removal Machine (GLD01)GEX · Traditional | Sanhe Meditech Co., Ltd. | 10/31/2025SE |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110)…GEX · Traditional | Boston Scientific Corporation | 10/30/2025SE |
| K251824 | Patriot DuoGEX · Traditional | Patriot Laser, LLC | 10/27/2025SE |
| K253100 | MultiPulse TFLGEX · Special | Asclepion Laser Technologies GmbH | 10/23/2025SE |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 10/23/2025SE |
| K252345 | Picosecond Laser Device (PF131-BI)GEX · Traditional | Risu Medical Technology Co., Ltd. | 10/23/2025SE |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U)GEX · Traditional | Sanhe Lefis Electronics Co., Ltd. | 10/20/2025SE |
| K250776 | Lithoblast Single Use Holmium Laser FibersGEX · Traditional | Dawell Medical, LLC | 10/14/2025SE |
| K251699 | The Botticelli (Model: Athena)GEX · Traditional | Bellamia Technologies, Inc. | 10/08/2025SE |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)GEX · Traditional | Jeisys Medical Incorporated | 10/03/2025SE |
| K242946 | Hestia (L200-A)GEX · Traditional | Senbitec Co., Ltd. | 10/03/2025SE |
| K252447 | Picosecond laser device (BMPS4)GEX · Traditional | Hebei Newangie Technology Co., Ltd. | 10/01/2025SE |
| K251919 | Thulium Laser System (Deluxlase)GEX · Traditional | Nanjing Bestview Laser S&T Co., Ltd. | 09/26/2025SE |
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…GEX · Traditional | Wuhan Dimed Laser Technology Co., Ltd. | 09/25/2025SE |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX · Traditional | Alma Lasers, Inc. | 09/24/2025SE |
| K251100 | IPGTFL-02GEX · Traditional | Ipg Medical Corporation | 09/19/2025SE |
| K242859 | VegaGEX · Traditional | Ibramed Equipamentos Médicos | 09/19/2025SE |
| K251457 | Diode laser therapy device (VADER)GEX · Traditional | Beijing Superlaser Technology Co., Ltd. | 09/03/2025SE |
| K251727 | GLAM LED Facial Mask (TB-2386F)GEX · Traditional | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 08/29/2025SE |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf)GEX · Traditional | Heager GmbH | 08/26/2025SE |
| K251801 | Diode laser device (BM091)GEX · Traditional | Hebei Newangie Technology Co., Ltd. | 08/08/2025SE |
| K251432 | OloGEX · Traditional | El.En S.P.A. | 08/06/2025SE |
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)GEX · Traditional | Shenzhen Lifotronic Technology Co., Ltd. | 07/30/2025SE |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 07/25/2025SE |
| K250504 | Leonardo DusterGEX · Abbreviated | Ceramoptec GmbH | 07/14/2025SE |
| K251149 | AviClear Laser SystemGEX · Traditional | Cutera, Inc. | 07/11/2025SE |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…GEX · Special | Boston Scientific Corporation | 07/09/2025SE |
| K250165 | PastelleGEX · Traditional | Wontech Co., Ltd. | 07/03/2025SE |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo)GEX · Traditional | Micro-Energy Medical Technology Co., Ltd. | 07/02/2025SE |
| K243701 | AuroLase® SystemGEX · Traditional | Nanospectra Biosciences, Inc. | 07/02/2025SE |
| K251329 | Diode laser device (RF3120-BI)GEX · Traditional | Risu Medical Technology Co., Ltd. | 06/27/2025SE |
| K251632 | Optimas MAX SystemGEX · Special | InMode , Ltd. | 06/26/2025SE |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1)GEX · Traditional | Beijing Sano Laser S&T Development Co.,Ltd | 06/12/2025SE |
| K250782 | Fractional CO2 Laser MachineGEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 06/12/2025SE |
| K243683 | Deka BluebeamGEX · Traditional | El.En S.P.A. | 06/12/2025SE |
| K250465 | CO2 Laser Machine (Lume)GEX · Traditional | Nanjing Bestview Laser S&T Co., Ltd. | 06/09/2025SE |
| K250722 | Nd: YAG Laser Therapy System (QN-1)GEX · Traditional | Hebei JT Medical Co., Ltd. | 06/06/2025SE |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico DermGEX · Traditional | Quanta System Spa | 06/06/2025SE |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)GEX · Traditional | Matelaser, Inc. | 05/30/2025SE |
| K251230 | The Alma Hybrid Laser SystemGEX · Special | Alma Lasers, Inc. | 05/21/2025SE |
| K251288 | VeincareGEX · Special | Wontech Co., Ltd. | 05/14/2025SE |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 05/14/2025SE |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1)GEX · Traditional | Shandong Moonlight Electronics Tech Co., Ltd. | 05/12/2025SE |
| K251094 | Alma VeilGEX · Special | Wontech Co., Ltd. | 05/06/2025SE |
| K242951 | Diode laser hair removal machine (QDTM-02)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 04/28/2025SE |
| K250206 | Diode laser system (Night Universe; Predator)GEX · Traditional | Ivylaser (Beijing) Technology Co.,Ltd | 04/24/2025SE |
| K250183 | CO2 Laser System (CO2 Laser SST-L23)GEX · Traditional | Zhuozhou Summer Star Technologies Co., Ltd. | 04/24/2025SE |
| K250809 | Stellar M22GEX · Special | Lumenis Be, Ltd. | 04/16/2025SE |
| K243044 | Alma HarmonyGEX · Traditional | Alma Lasers, Inc. | 04/11/2025SE |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)GEX · Special | Wuhan Pioon Technology Co., Ltd. | 04/04/2025SE |
| K250189 | AdvaTxGEX · Traditional | Advalight Aps | 04/01/2025SE |
| K250018 | Medical Diode Laser Systems (THEIA808)GEX · Traditional | Gigaalaser Company , Ltd. | 04/01/2025SE |
| K243630 | Medical Laser System Incanto / Evoline Platinum /EvolineGEX · Traditional | Solar LS Cjsc | 03/21/2025SE |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…GEX · Traditional | Gigaalaser Company , Ltd. | 03/19/2025SE |
| K250113 | neoLaser Laser Surgery FibersGEX · Traditional | G.N.S Neolaser , Ltd. | 03/13/2025SE |
| K243993 | Photon Therapy Apparatus (BL-10)GEX · Traditional | Xemis Medical Technology (Shenzhen) Co., Ltd. | 03/13/2025SE |
| K243957 | PicoalexGEX · Traditional | Wontech Co., Ltd. | 03/12/2025SE |
| K242207 | Noable LaserGEX · Traditional | Daeju Meditech Engineering Co., Ltd. | 03/07/2025SE |
| K242943 | Q Switched Nd:YAG Laser machine (QNHF-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 03/03/2025SE |
| K234004 | Medical diode laser systems (CHARISMA, REGAL)GEX · Traditional | Reveal Lasers , Ltd. | 02/20/2025SE |
| K243588 | Single Use CO2 Laser Fiber (HAF005001)GEX · Traditional | Quanta System Spa | 02/19/2025SE |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)GEX · Traditional | Wontech Co., Ltd. | 02/14/2025SE |
| K241527 | Pastelle ProGEX · Traditional | Wontech Co., Ltd. | 02/14/2025SE |
| K243780 | HELIOS 785 Pico (1754V2)GEX · Traditional | Laseroptek Co., Ltd. | 02/07/2025SE |
| K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…GEX · Traditional | Guangzhou Chuang Zao Mei Technology Co., Ltd. | 02/06/2025SE |
| K241270 | BTL-754GEX · Traditional | BTL Industries, Inc. | 01/30/2025SE |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1)GEX · Traditional | Beijing Sano Laser S&T Development Co.,Ltd | 01/27/2025SE |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)GEX · Traditional | Bios S.R.L. | 12/30/2024SE |
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…GEX · Traditional | Jiangxi Medex Technology Co., Ltd. | 12/26/2024SE |
| K243037 | Diode Laser System model Dawn-SGEX · Traditional | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 12/26/2024SE |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF…GEX · Traditional | Jiangxi Medex Technology Co., Ltd. | 12/22/2024SE |
| K243147 | LGO-Surgical Laser FibersGEX · Traditional | Light Guide Optics International , Ltd. | 12/21/2024SE |
| K242534 | HandPICO Fractional Laser Handpiece TipGEX · Traditional | Vydence Medical | 12/20/2024SE |
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…GEX · Traditional | Beijing Adss Development Co., Ltd. | 12/20/2024SE |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE)GEX · Traditional | Allengers Global Healthcare Private Limited | 12/17/2024SE |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 11/19/2024SE |
| K241498 | Diode laser Treatment System (K18)GEX · Traditional | Hebei Keylaser Sci-Tech Co.,Ltd | 11/18/2024SE |
| K241930 | VeincareGEX · Traditional | Wontech Co., Ltd. | 11/14/2024SE |
| K241646 | Ortiv (Ortiv-Bl, Ortiv-Wh)GEX · Traditional | Mvitro Co., Ltd. | 11/01/2024SE |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)GEX · Traditional | Medency S.R.L. | 10/24/2024SE |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2)GEX · Traditional | Weifang Mingliang Electronics Co., Ltd. | 10/23/2024SE |
| K242132 | FreddoGEX · Traditional | Fabinject Lndustria E Comercio Lmportacao E… | 10/18/2024SE |
| K242035 | Accure Laser SystemGEX · Traditional | Accure Acne, Inc. | 10/11/2024SE |
| K241951 | Lasya-TrinityGEX · Traditional | BLUECORE COMPANY Co., Ltd. | 10/10/2024SE |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTGEX · Traditional | Quanta System Spa | 10/10/2024SE |
| K231948 | MediyagGEX · Special | Medicreations, LLC | 10/09/2024SE |
| K242206 | ActivoGEX · Traditional | Daeju Meditech Engineering Co., Ltd. | 09/27/2024SE |
| K241860 | Diode Laser Hair Removal SystemGEX · Traditional | Beijing Winkonlaser Technology Limited | 09/25/2024SE |
| K240604 | Mtone Evo (Mtone Evo)GEX · Traditional | M&T S.R.L. | 09/20/2024SE |
| K241771 | Liftendo; Liftendo 2.0GEX · Traditional | Medical San Indústria DE Equipamentos Médicos… | 09/16/2024SE |
| K242349 | FoLixGEX · Special | Lumenis Be, Ltd. | 09/09/2024SE |
| K241672 | Copro 3GEX · Traditional | Amt Engineering Co., Ltd. | 09/06/2024SE |
| K242251 | Litho 60; Litho 100; Litho 150GEX · Special | Quanta System Spa | 09/03/2024SE |
| K242202 | LightWalker Laser System FamilyGEX · Special | Fotona D.O.O. | 08/23/2024SE |
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Special | Olympus Surgical Technologies America | 08/23/2024SE |
| K242142 | Fraxel® FTX Laser SystemGEX · Traditional | Solta Medical | 08/21/2024SE |
| K241699 | Super VeloceGEX · Traditional | Ilooda Co,., Ltd. | 08/13/2024SE |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1)GEX · Traditional | Weifang Dragonfly Electronics Technology Co., Ltd. | 08/13/2024SE |
| K241656 | Eneka SelectifGEX · Traditional | Termosalud | 08/12/2024SE |
| K231950 | MedidiodeGEX · Special | Medicreations, LLC | 08/09/2024SE |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 08/02/2024SE |
| K241293 | LED Light Therapy Device, ELIXIR MDGEX · Traditional | Yassen Wellness, LLC | 07/08/2024SE |
| K241600 | DermablateGEX · Special | Asclepion Laser Technologies GmbH | 07/03/2024SE |
| K241406 | LavieenGEX · Traditional | Wontech Co., Ltd. | 06/28/2024SE |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY)GEX · Traditional | Wontech Co., Ltd. | 06/24/2024SE |
| K241459 | MOTUS PRO FamilyGEX · Special | El.En S.P.A. | 06/21/2024SE |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy)GEX · Traditional | Ivylaser (Beijing) Technology Co.,Ltd | 06/20/2024SE |
| K240747 | Medical Diode Laser (M2-GK)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 06/17/2024SE |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)GEX · Traditional | Bios S.R.L. | 06/14/2024SE |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170EGEX · Special | Sun Pharmaceutical Industries, Inc. | 06/13/2024SE |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGENDGEX · Traditional | Ami, Inc. | 06/12/2024SE |
| K240644 | Medical Diode Laser (S1Pro)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 06/10/2024SE |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)GEX · Traditional | Aesthetic Technology, Ltd. | 06/04/2024SE |
| K240159 | InnoVoyce VYLOGEX · Traditional | Innovoyce | 05/29/2024SE |
| K240874 | Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)GEX · Traditional | Theralaser Medtech (China) Co., Ltd. | 05/28/2024SE |
| K233344 | Regenalase Laser SystemGEX · Traditional | Ipg Medical | 05/28/2024SE |
| K240520 | Diode Laser Hair Removal System (SH-VD910)GEX · Traditional | Beijing Sea Heart International Science and… | 05/20/2024SE |
| K240474 | Multi-function Platform Systems (BL-M10)GEX · Traditional | Shanghai Bele Medical Technology Co.,Ltd | 05/20/2024SE |
| K240752 | Deka ToroGEX · Traditional | El.En S.P.A. | 05/16/2024SE |
| K240386 | Picosecond Nd:YAG Laser Systems (BL-C10)GEX · Traditional | Shanghai Bele Medical Technology Co.,Ltd | 05/16/2024SE |
| K233803 | UltraClear Laser System (N/A)GEX · Traditional | Acclaro Corporation | 05/08/2024SE |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDDGEX · Traditional | Innovaquartz, LLC | 05/03/2024SE |
| K232858 | ORskin BlueGEX · Traditional | Megabay S.A. | 05/01/2024SE |
| K240118 | Picosecond Nd:YAG Laser SystemGEX · Traditional | Smedtrum Medical Technology Co., Ltd. | 04/30/2024SE |
| K240816 | MeDioStarGEX · Special | Asclepion Laser Technologies GmbH | 04/23/2024SE |
| K232133 | Co2 Laser System, Models: PureLase And VanLaseGEX · Traditional | Cpmt Laser (Canadian Pioneer Medical Technology… | 04/16/2024SE |
| K233757 | TitanPico Laser Workstation (PICO-450)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 04/11/2024SE |
| K234057 | NirvanaGEX · Traditional | El.En S.P.A. | 04/10/2024SE |
| K234085 | LUNE PureHygieneGEX · Traditional | Enamel Pure | 03/25/2024SE |
| K240179 | Medical Diode Laser (Model: L2)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 03/21/2024SE |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesGEX · Traditional | Ipg Medical Corporation | 03/21/2024SE |
| K240537 | Smartxide ProGEX · Special | El.En S.P.A. | 03/20/2024SE |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser)GEX · Traditional | Wontech Co., Ltd. | 03/15/2024SE |
| K240497 | Smartxide Tetra ProGEX · Special | El.En S.P.A. | 03/12/2024SE |
| K240132 | EmoLED (v. 2-USA)GEX · Traditional | Emoled, Srl | 03/12/2024SE |
| K240396 | Elite iQ PRO (M122K1)GEX · Special | Cynosure, LLC | 03/08/2024SE |
| K231876 | MultiPulse HoPLUSGEX · Traditional | Asclepion Laser Technologies GmbH | 02/22/2024SE |
| K231896 | Diode Laser Therapy SystemGEX · Traditional | Beijing Adss Development Co., Ltd. | 02/20/2024SE |
| K231514 | AzureGEX · Traditional | Daeshin Enterprise Co., Ltd. | 02/14/2024SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3110-2026 Class II | Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that…Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud… | Lutronic Corporation | 08/06/2026Open, Classified |
| Z-2554-2026 Class II | Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.Software anomaly that causes a false display of error code 5018. | IPG Medical Corporation | 05/05/2026Open, Classified |
| Z-1695-2026 Class II | Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser…Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in… | Olympus Corporation of the Americas | 02/27/2026Open, Classified |
| Z-1694-2026 Class II | Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE…Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in… | Olympus Corporation of the Americas | 02/27/2026Open, Classified |
| Z-1558-2026 Class II | CLARITY II Laser System; Model No. 1110200210.Reports of devices sparking/popping and potentially burning patients. | Lutronic Corporation | 01/27/2026Open, Classified |
| Z-1130-2026 Class II | Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b…The console label for affected devices is missing the "DANGER" symbol. | Leaseir Technologies Slu | 12/15/2025Completed |
| Z-2344-2025 Class II | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including…The potential for unsterilized product within finished product labeled as sterile. | Lumenis, Ltd. | 07/22/2025Open, Classified |
| Z-1923-2025 Class II | Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser…Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady… | Olympus Corporation of the Americas | 05/06/2025Open, Classified |
| Z-1922-2025 Class II | Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser…Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady… | Olympus Corporation of the Americas | 05/06/2025Open, Classified |
| Z-1921-2025 Class II | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed…Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady… | Olympus Corporation of the Americas | 05/06/2025Open, Classified |
| Z-1920-2025 Class II | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed…Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady… | Olympus Corporation of the Americas | 05/06/2025Open, Classified |
| Z-1715-2025 Class II | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed…Preset treatment parameters are not consistently being used in accordance with the IFU. | Olympus Corporation of the Americas | 04/04/2025Open, Classified |
| Z-1290-2025 Class II | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H…The initial current in certain chargers may lead to overheating and damage to the power resistors on the… | Lumenis, Ltd. | 01/23/2025Open, Classified |
| Z-0556-2025 Class II | Diode Laser Hair Removal model: WLA-01All model WLA-01 systems sold to US customers are found to have labeling non-compliances | Wingderm Electro-Optics Ltd. | 08/23/2024Open, Classified |
| Z-0135-2025 Class II | Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection…The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo… | Olympus Corporation of the Americas | 08/13/2024Open, Classified |
| Z-0134-2025 Class II | Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection…The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo… | Olympus Corporation of the Americas | 08/13/2024Open, Classified |
| Z-2506-2024 Class II | Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWLDifficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical… | Olympus Corporation of the Americas | 05/31/2024Open, Classified |
| Z-2505-2024 Class II | Soltive Pro SuperPulsed Laser System, Model TFL-SLSDifficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical… | Olympus Corporation of the Americas | 05/31/2024Open, Classified |
| Z-2504-2024 Class II | Soltive Premium SuperPulsed Laser System, Model TFL-PLSDifficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical… | Olympus Corporation of the Americas | 05/31/2024Open, Classified |
| Z-1809-2024 Class II | LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF:…Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these… | Karl Storz Endoscopy | 04/01/2024Open, Classified |
| Z-1385-2024 Class II | SOLTIVE Premium SuperPulsed Laser (TFL-PLS )A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug… | Olympus Corporation of the Americas | 01/29/2024Open, Classified |
| Z-1384-2024 Class II | SOLTIVE Pro SuperPulsed Laser (TFL-SLS )A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug… | Olympus Corporation of the Americas | 01/29/2024Open, Classified |
| Z-0778-2024 Class II | Accure Laser System, Model: PFMS00004Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of… | Accure Acne, Inc | 12/06/2023Open, Classified |
| Z-0718-2024 Class II | SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BSAffected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead… | Olympus Corporation of the Americas | 12/04/2023Open, Classified |
| Z-0717-2024 Class II | Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFCThe strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not… | Olympus Corporation of the Americas | 12/04/2023Open, Classified |
| Z-0716-2024 Class II | Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150…The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not… | Olympus Corporation of the Americas | 12/04/2023Open, Classified |
| Z-0748-2024 Class II | SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S…Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber… | Olympus Corporation of the Americas | 12/01/2023Open, Classified |
| Z-0095-2024 Class II | MED-810A Zemits NDPrime Laser productsAdvance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation… | Advance-Esthetic LLC | 10/09/2023Open, Classified |
| Z-2234-2023 Class II | Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that…Manufactured with the incorrect component may result in lower power output and degradation or dimming of the… | Boston Scientific Corporation | 05/25/2023Open, Classified |
| Z-2233-2023 Class II | Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that…Manufactured with the incorrect component may result in lower power output and degradation or dimming of the… | Boston Scientific Corporation | 05/25/2023Open, Classified |
| Z-2232-2023 Class II | Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from…Manufactured with the incorrect component may result in lower power output and degradation or dimming of the… | Boston Scientific Corporation | 05/25/2023Open, Classified |
| Z-2231-2023 Class II | Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from…Manufactured with the incorrect component may result in lower power output and degradation or dimming of the… | Boston Scientific Corporation | 05/25/2023Open, Classified |
| Z-2230-2023 Class II | Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that…Manufactured with the incorrect component may result in lower power output and degradation or dimming of the… | Boston Scientific Corporation | 05/25/2023Open, Classified |
| Z-2229-2023 Class II | Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that…Manufactured with the incorrect component may result in lower power output and degradation or dimming of the… | Boston Scientific Corporation | 05/25/2023Open, Classified |
| Z-2228-2023 Class II | Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits…Manufactured with the incorrect component may result in lower power output and degradation or dimming of the… | Boston Scientific Corporation | 05/25/2023Open, Classified |
| Z-1819-2022 Class II | VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box…OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional… | Angiodynamics, Inc. | 08/10/2022Open, Classified |
| Z-1392-2022 Class III | GreenLight HPSEA Laser Fibers, UPN 0010-2092Several complaints were received for the affected lot; users received a "Fiber type does not match card… | Boston Scientific Corporation | 05/31/2022Open, Classified |
| Z-1296-2022 Class II | SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball…Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton… | Olympus Corporation of the Americas | 05/26/2022Terminated |
| Z-2405-2021 Class II | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device…The sterile barrier seal may be compromised. | Clarus Medical, Llc | 07/27/2021Terminated |
| Z-2294-2021 Class II | Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System…Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W… | Olympus Corporation of the Americas | 06/30/2021Terminated |
| Z-1844-2021 Class II | Quanta System Sterile Optical Laser Fiber, reusableProduct sterility is potentially compromised. | Quanta System, S.p.A. | 04/27/2021Terminated |
| Z-1843-2021 Class II | Quanta System Sterile Optical Laser Fiber, single useProduct sterility is potentially compromised. | Quanta System, S.p.A. | 04/27/2021Terminated |
| Z-1842-2021 Class II | Olympus Sterile Optical Laser Fiber, single use and reusableProduct sterility is potentially compromised. | Quanta System, S.p.A. | 04/27/2021Terminated |
| Z-1782-2021 Class II | Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02…single use devices labeled as sterile may not have been adequately sterilized | Clinical Laserthermia Systems AB | 04/01/2021Terminated |
| Z-2690-2020 Class II | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005…Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Medtronic Sofamor Danek USA Inc | 06/08/2020Terminated |
| Z-1798-2020 Class II | MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for…To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which… | Boston Scientific Corporation | 03/30/2020Terminated |
| Z-0440-2021 Class II | Class IV New Era medical laser deviceThe firm failed to comply with the applicable standards regarding Electronic Product Radiation Control… | Inova Lasers LLC | 01/29/2020Open, Classified |
| Z-0209-2020 Class II | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant…The canister neck bushing may become loose and separate from the body of the canister during use. The issue… | Candela Corporation | 09/10/2019Terminated |
| Z-0208-2020 Class II | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant…The canister neck bushing may become loose and separate from the body of the canister during use. The issue… | Candela Corporation | 09/10/2019Terminated |
| Z-0207-2020 Class II | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C…The canister neck bushing may become loose and separate from the body of the canister during use. The issue… | Candela Corporation | 09/10/2019Terminated |