Alma Lasers, Inc.
Medical device manufacturer in Buffalo Grove, IL.
34510(k) clearances
0PMA approvals
0recalls
Device types
- GEX Powered Laser Surgical Instrument 22
- GEI Electrosurgical, Cutting & Coagulation &… 4
- NUV Massager, Vacuum, Light Induced Heating 2
- ILY Lamp, Infrared, Therapeutic Heating 1
- PDZ Lasers For Temporary Increase Of Clear Nail… 1
- IMI Ultrasonic Diathermy For Use In Applying… 1
- MUU System, Suction, Lipoplasty 1
- ONF Powered Light Based Non-Laser Surgical… 1
- OAP Laser, Comb, Hair 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251684 | Alma TED+ SystemOAP · Traditional | 06/05/2026SE |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX · Traditional | 09/24/2025SE |
| K251230 | The Alma Hybrid Laser SystemGEX · Special | 05/21/2025SE |
| K243044 | Alma HarmonyGEX · Traditional | 04/11/2025SE |
| K233024 | Alma HarmonyGEX · Traditional | 02/08/2024SE |
| K230308 | Alma HarmonyGEX · Traditional | 03/01/2023SE |
| K230371 | The Alma Soprano TitaniumGEX · Special | 02/22/2023SE |
| K222064 | The Alma Soprano TitaniumGEX · Traditional | 10/12/2022SE |
| K212073 | Alma Diode Tabletop LaserGEX · Traditional | 07/14/2022SE |
| K201520 | The Alma Opus System, Colibri Applicator and TipsGEI · Traditional | 10/27/2021SE |
| K203441 | The Alma Hybrid Laser SystemGEX · Traditional | 07/02/2021SE |
| K181298 | Harmony XL Multi-Application PlatformONF · Special | 06/13/2018SE |
| K172193 | Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms…GEX · Traditional | 01/09/2018SE |
| K171242 | Alma LipoFlow SystemMUU · Traditional | 07/14/2017SE |
| K170850 | Alma QGEX · Traditional | 06/15/2017SE |
| K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…GEX · Traditional | 05/31/2017SE |
| K160075 | Accent XLIMI · Traditional | 08/17/2016SE |
| K140009 | Soprano Ice Multi-Application & Multi-Technology PlatformGEX · Traditional | 08/29/2014SE |
| K140005 | Alma Diode Tabletop LaserGEX · Traditional | 07/18/2014SE |
| K121150 | Alma Lasers Family of Pixel RF TipsGEI · Traditional | 09/21/2012SE |
| K113810 | Modified Alma Lasers Harmony 1064NM (Nd:Yag) ModulesPDZ · Traditional | 03/08/2012SE |
| K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…GEX · Special | 09/13/2011SE |
| K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemNUV · Traditional | 01/21/2011SE |
| K103501 | Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesGEX · Special | 01/14/2011SE |
| K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsGEX · Special | 09/28/2010SE |
| K090571 | Alma Lasers ALEX755 ModuleGEX · Traditional | 08/13/2009SE |
| K083848 | Alma Lasers Soprano XL Multi-Application PlatformGEX · Traditional | 04/14/2009SE |
| K082622 | Alma Lasers Accent B-Shape Massager Handpiece/ModuleNUV · Traditional | 01/12/2009SE |
| K080463 | Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesGEX · Traditional | 07/23/2008SE |
| K072182 | Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060GEX · Traditional | 06/27/2008SE |
| K072564 | Alma Lasers Harmony XL Multi-Application PlatformGEX · Traditional | 05/23/2008SE |
| K080318 | Alma Laser Nir ModuleILY · Traditional | 03/07/2008SE |
| K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLGEI · Special | 10/05/2007SE |
| K070004 | AccentGEI · Traditional | 04/23/2007SE |