FDA 510(k) Applications for Medical Device Product Code "LEJ"
(Booth, Sun Tan)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K152141 | BLV Licht-und Vakuumtechnik GmbH | High Pressure Tanning Lamps | 02/25/2016 |
| K152273 | Cosmedico Light, Inc | Cosmedico Ultraviolet Lamps of Various Models | 10/30/2015 |
| K152095 | COSMEDICO LIGHT, INC. | Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) | 10/28/2015 |
| K150778 | COSMEDICO LIGHT, INC. | Various Brands of Ultraviolet Lamps | 05/29/2015 |
| K180581 | Feilo Sylvania Germany GmbH | UV Lamps for Sunlamp Products | 06/22/2018 |
| K151674 | G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH | Ultraviolet Sun Tanning Lamp | 10/20/2015 |
| K151905 | HEARTLAND TANNING, INC. | 3400E series; E5400 series; E6400 series; Sundazzler series | 03/01/2016 |
| K152405 | IBL ACQUISITIONS LLC | IBL 5000 Tanning Booth | 09/01/2016 |
| K152436 | Interlectric Corporation | Suntanning Lamps | 12/07/2015 |
| K152336 | J & B PRODUCTS LTD DBA HEX TANNING | HEX tanning booth | 05/02/2016 |
| K180555 | JK Holding GmbH | Ergoline Prestige 1600 Hybrid Performance | 10/11/2018 |
| K151400 | JK HOLDING GmbH | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products | 09/16/2015 |
| K190173 | JK-Holding GmbH | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | 05/10/2019 |
| K183539 | JK-Holding GmbH | Ergoline Sunrise 7200 Hybrid Technology | 04/08/2019 |
| K220500 | JK-Holding GmbH | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline | 07/01/2022 |
| K173565 | JK-Holding GmbH | Sunrise 6200, Sunrise 7200 | 02/14/2018 |
| K151962 | KBL AG | KBL Sunlamp Products (= Device Bundling name) | 09/15/2016 |
| K191881 | KBL GmbH | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | 10/28/2019 |
| K151721 | KDB INC. (DBA) SPERTI SUNLAMP | FIJI SUN FLUORESCENT TANNING UNIT | 06/22/2018 |
| K151370 | LIGHT SOURCES, INC. | UV Lamps for Indoor Tanning Devices | 12/17/2015 |
| K180576 | LPI, Inc. | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | 04/19/2018 |
| K152452 | MEDTEK LIGHTING CORP D/B/A PEACOCK TANNING | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 | 05/19/2016 |
| K152364 | PC Marketing, Inc. | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS | 04/14/2016 |
| K181455 | ProSun International LLC | ProSun sunlamp products, Luxura sunlamp products | 09/10/2018 |
| K152233 | Sportarredo Group S.C. | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | 01/27/2016 |
| K161394 | Sportarredo Group S.C. | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | 07/06/2017 |
| K152238 | SUN CAPSULE, INC. | Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/ | 03/04/2016 |
| K152423 | Sunfire Industries Inc. | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy | 05/20/2016 |
| K152412 | Tanses Technologies inc. | T-32;T-40;T-44;T-52;T-72;TT-50 | 04/29/2016 |
| K090831 | TANTHERA, INC. | TANTHERA-T35 | 05/29/2009 |
| K221523 | Unilam Co., Ltd. | Tanning Lamp | 02/15/2023 |
| K143043 | UNILAM CO., LTD. | Tanning Lamp | 04/02/2015 |
| K151841 | Wolff System Technology Corp. | Ultraviolet Sunlamps | 10/05/2015 |
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