Booth, Sun Tan
FDA product code LEJ · Class II (moderate risk) · 21 CFR 878.4635 · General, Plastic Surgery
81510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Jk-Holding GmbH 6
- Cosmedico Light, Inc. 4
- Kohler 2
- Sun Ind., Inc. 2
- Unilam Co., Ltd. 2
- Wolff System Technology Corp. 2
- Sportarredo Group S.C. 2
- Eurocut, Ltd. 2
- Kbl GmbH 2
- Ultra Tan Intl. AB 2
- Health Systems Intl., Inc. 2
- Sunbronze 2
- Rami-Tan 2
- Sun Valley Tans, Inc. 1
- The Marketing Exchange, Inc. 1
- Sun Tan Enterprises, Inc. 1
- Classic Tan, Inc. 1
- Solar Pacific 1
- Tan-Year Round, Inc. 1
- Sun Ray Mfg., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221523 | Tanning LampLEJ · Traditional | Unilam Co., Ltd. | 02/15/2023SE |
| K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness…LEJ · Traditional | Jk-Holding GmbH | 07/01/2022SE |
| K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunLEJ · Special | Kbl GmbH | 10/28/2019SE |
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid…LEJ · Traditional | Jk-Holding GmbH | 05/10/2019SE |
| K183539 | Ergoline Sunrise 7200 Hybrid TechnologyLEJ · Traditional | Jk-Holding GmbH | 04/08/2019SE |
| K180555 | Ergoline Prestige 1600 Hybrid PerformanceLEJ · Traditional | Jk Holding GmbH | 10/11/2018SE |
| K181455 | ProSun sunlamp products, Luxura sunlamp productsLEJ · Traditional | Prosun International, LLC | 09/10/2018SE |
| K180581 | UV Lamps for Sunlamp ProductsLEJ · Traditional | Feilo Sylvania Germany GmbH | 06/22/2018SE |
| K151721 | Fiji Sun Fluorescent Tanning UnitLEJ · Abbreviated | Kdb Inc. (Dba) Sperti Sunlamp | 06/22/2018SE |
| K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and…LEJ · Traditional | Lpi, Inc. | 04/19/2018SE |
| K173565 | Sunrise 6200, Sunrise 7200LEJ · Traditional | Jk-Holding GmbH | 02/14/2018SE |
| K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxLEJ · Traditional | Sportarredo Group S.C. | 07/06/2017SE |
| K151962 | KBL Sunlamp Products (= Device Bundling name)LEJ · Traditional | Kbl AG | 09/15/2016SE |
| K152405 | IBL 5000 Tanning BoothLEJ · Traditional | Ibl Acquisitions, LLC | 09/01/2016SE |
| K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R…LEJ · Traditional | Sunfire Industries, Inc. | 05/20/2016SE |
| K152452 | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200LEJ · Traditional | Medtek Lighting Corp D/B/A Peacock Tanning | 05/19/2016SE |
| K152336 | HEX tanning boothLEJ · Traditional | J & B Products Ltd Dba Hex Tanning | 05/02/2016SE |
| K152412 | T-32;T-40;T-44;T-52;T-72;TT-50LEJ · Traditional | Tanses Technologies, Inc. | 04/29/2016SE |
| K152364 | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUSLEJ · Traditional | Pc Marketing, Inc. | 04/14/2016SE |
| K152238 | Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun…LEJ · Traditional | Sun Capsule, Inc. | 03/04/2016SE |
| K151905 | 3400E series; E5400 series; E6400 series; Sundazzler seriesLEJ · Traditional | Heartland Tanning, Inc. | 03/01/2016SE |
| K152141 | High Pressure Tanning LampsLEJ · Traditional | Blv Licht-Und Vakuumtechnik GmbH | 02/25/2016SE |
| K152233 | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxLEJ · Traditional | Sportarredo Group S.C. | 01/27/2016SE |
| K151370 | UV Lamps for Indoor Tanning DevicesLEJ · Traditional | Light Sources, Inc. | 12/17/2015SE |
| K152436 | Suntanning LampsLEJ · Traditional | Interlectric Corporation | 12/07/2015SE |
| K152273 | Cosmedico Ultraviolet Lamps of Various ModelsLEJ · Traditional | Cosmedico Light, Inc. | 10/30/2015SE |
| K152095 | Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide…LEJ · Traditional | Cosmedico Light, Inc. | 10/28/2015SE |
| K151674 | Ultraviolet Sun Tanning LampLEJ · Traditional | G.I.E.- Gesellschaft Fur Lichttechnische… | 10/20/2015SE |
| K151841 | Ultraviolet SunlampsLEJ · Traditional | Wolff System Technology Corp. | 10/05/2015SE |
| K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp ProductsLEJ · Traditional | Jk Holding GmbH | 09/16/2015SE |
| K150778 | Various Brands of Ultraviolet LampsLEJ · Traditional | Cosmedico Light, Inc. | 05/29/2015SE |
| K143043 | Tanning LampLEJ · Traditional | Unilam Co., Ltd. | 04/02/2015SE |
| K090831 | TANTHERA-T35LEJ · Traditional | Tanthera, Inc. | 05/29/2009SE |
| K944015 | Harpo Sunbed, Sun Tanning MachineLEJ · Traditional | Harpo Industries | 09/06/1994SE |
| K943656 | Alpha Solar System Tanning BedLEJ · Traditional | Heartland Tan Systems | 08/15/1994SE |
| K936314 | Odyssey Tan 2000LEJ · Traditional | Fitness TO Go, Inc. | 07/22/1994SE |
| K940753 | Tan America Sun UpLEJ · Traditional | Tan America | 04/05/1994SE |
| K940672 | Cleo TL80W Professional Cleo TL80W Professional R, Cleo TL100 W ProfessionalLEJ · Traditional | Philips Lighting Co. | 03/18/1994SE |
| K932483 | SundashLEJ · Traditional | Sun Ind., Inc. | 02/22/1994SE |
| K935854 | Ultraviolet Lamps for TanningLEJ · Traditional | Cosmedico Light, Inc. | 01/24/1994SE |
| K931661 | Ultrabronz Series 800 (Eclipse) Tanning BedLEJ · Traditional | Eurocut, Ltd. | 12/17/1993SE |
| K931660 | Ultrabronz Series 400 Tanning BedLEJ · Traditional | Eurocut, Ltd. | 12/17/1993SE |
| K932418 | Sunbronze Tanning LampsLEJ · Traditional | Ess Lighting | 12/09/1993SE |
| K923759 | Fluorescent T12 Uva Tanning LampLEJ · Traditional | Quality Lamp, Inc. | 12/09/1993SE |
| K904644 | Eurosun Models - ES-2400, Es-Vho and ES-16LEJ · Traditional | Eurosun, Inc. | 12/28/1990SE |
| K901714 | Lifestyle Home Tanning UnitsLEJ · Traditional | Life Products, Inc. | 06/27/1990SE |
| K896983 | Sunbronze SB24C/65 UltraLEJ · Traditional | Sunbronze | 01/03/1990SE |
| K895409 | Remington Tanfastic Countertop Facial TannerLEJ · Traditional | Remington Products Company, LLC | 10/20/1989SE |
| K895325 | Suntanning BedLEJ · Traditional | Sunbronze | 09/15/1989SE |
| K882331 | Shaw Sun Systems Model 1600LEJ · Traditional | Shaw Sun Systems | 06/22/1988SE |
| K881492 | Mti Wolff System, Tanning BedLEJ · Traditional | Health Systems Intl., Inc. | 04/19/1988SE |
| K881409 | Sun Shell (Sun Tanning Bed)LEJ · Traditional | Indoor Sun Systems, Inc. | 04/19/1988SE |
| K881353 | Mti Wolff SystemLEJ · Traditional | Health Systems Intl., Inc. | 04/06/1988SE |
| K875190 | Ultra Tan Purple ProLEJ · Traditional | Ultra Tan Intl. AB | 01/14/1988SE |
| K875189 | Ultra Tan Purple MintLEJ · Traditional | Ultra Tan Intl. AB | 01/14/1988SE |
| K873589 | Perfect Suntanning BedLEJ · Traditional | Wolff System Technology Corp. | 10/29/1987SE |
| K813208 | K60 Habitat Environment EnclosureLEJ · Traditional | Kohler | 12/31/1981SE |
| K813207 | K51,K52 Environment EnclosureLEJ · Traditional | Kohler | 12/31/1981SE |
| K810366 | Fancy Tan SunbedLEJ · Traditional | Fancy Tan, Inc. | 03/05/1981SE |
| K803189 | Sunscene Tanning StudioLEJ · Traditional | Sunscene Tanning Studio | 01/28/1981SE |
| K803090 | Sunmaker (Sun Tanning Bed)LEJ · Traditional | Sunmaker, Inc. | 01/22/1981SE |
| K802756 | Semi-Oval Modular Suntanning BoothLEJ · Traditional | Tannhut | 01/22/1981SE |
| K803061 | Sun Tanning DevicesLEJ · Traditional | Mutzhas Corp. | 01/13/1981SE |
| K802304 | Solar ToneLEJ · Traditional | Bloomex International, Inc. | 12/01/1980SE |
| K802134 | JK Int'L, Inc. Soltron Uva Tanning BedLEJ · Traditional | Mottek Intl. Corp. | 10/23/1980SE |
| K801675 | U.I. OctosonLEJ · Traditional | Ausonics Pty , Ltd. | 10/23/1980SE |
| K801925 | Cabanna Tan SunlampLEJ · Traditional | The Marketing Exchange, Inc. | 10/03/1980SE |
| K801752 | Rami Tan Ultraviolet B BoothLEJ · Traditional | Rami-Tan | 09/16/1980SE |
| K801751 | Rami Ultraviolet a BoothLEJ · Traditional | Rami-Tan | 09/16/1980SE |
| K801674 | Sun Room Tanning BoothLEJ · Traditional | Sun Tan Enterprises, Inc. | 09/16/1980SE |
| K801543 | Sun Valley TansLEJ · Traditional | Sun Valley Tans, Inc. | 09/16/1980SE |
| K801542 | Sunbed/Sunroof or Suncouch/SunskyLEJ · Traditional | Sunfit, Inc. | 08/20/1980SE |
| K801521 | Classic Tan Tanning BoothLEJ · Traditional | Classic Tan, Inc. | 08/20/1980SE |
| K801520 | Solar Pacific Uva Sunlamp DeviceLEJ · Traditional | Solar Pacific | 08/20/1980SE |
| K801429 | SunsationLEJ · Traditional | Fashion, Inc. | 07/28/1980SE |
| K801341 | Tan Year Round Sun BedLEJ · Traditional | Tan-Year Round, Inc. | 07/21/1980SE |
| K801163 | Sunburst, Sun Systems or BC2LEJ · Traditional | Sun Ray Mfg., Inc. | 07/21/1980SE |
| K801095 | The Sun BoothLEJ · Traditional | Sun Booths , Ltd. | 07/21/1980SE |
| K800744 | Suntana Sunbed #SB-1 & Sunbrella #SU-1LEJ · Traditional | Sun Ind., Inc. | 06/04/1980SE |
| K800896 | Wolff SystemLEJ · Traditional | Wolff System GmbH | 05/30/1980SE |
| K801029 | Clinical Data System (Cam) ModuleLEJ · Traditional | Adac Laboratories | 05/28/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2636-2023 Class II | ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning DeviceIn some cases the communication isolator installed in the Model 52X can cause a disturbance in the… | J&T Health and Wellness LLC | 03/31/2023Open, Classified |
| Z-1177-2019 Class II | ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following:…ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which… | ProSun International, LLC | 12/10/2018Terminated |
| Z-1176-2019 Class II | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the…ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which… | ProSun International, LLC | 12/10/2018Terminated |
| Z-0319-2018 Class II | Sundream 12 V tanning bedThe 30 minute maximum tanning time has been reduced to 20 minutes. | ProSun International, LLC | 12/02/2017Terminated |
| Z-2635-2014 Class II | SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of…The integrity of the wires inside main electrical chord become compromised from excessive flexing (during… | JK Products & Services, Inc | 07/25/2014Terminated |
| Z-2334-2012 Class II | SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is…The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some… | JK Products & Services, Inc | 07/08/2005Terminated |