510(k) K152095
- Device
- Ultraviolet Lamps Intended For Use In Sunlamp Products (commonly Known As Metal Halide Sunlamps)
- Applicant
- COSMEDICO LIGHT, INC.
- 510(k) number
- K152095
- Product code
- LEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-28
- Date received
- 2015-07-28
- Regulation
- 878.4635
- Classification name
- Booth, Sun Tan
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN SCHLITT
- Address
- 233 Libbey Industrial Pkwy. Weymouth MA US 02189 02189
FDA Registration Numbers#
- 3009973354
- 9680413
- 2311923
- 8021093
- 3003882673
- 3007123863
- 9615023
- 1450790
- 1318319
- 3008799671
- 3003994709
- 1221013
- 1058796
- 1022129
- 1054665
- 3006116732
- 9616478
- 3015276821
- 8010905
- 8022254
Source Documents#
Other 510(k) Records For Product Code LEJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221523 | Tanning Lamp | Unilam Co., Ltd. | 2023-02-15 |
| K220500 | 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 Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline | Jk-Holding GmbH | 2022-07-01 |
| K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | Kbl GmbH | 2019-10-28 |
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | Jk-Holding GmbH | 2019-05-10 |
| K183539 | Ergoline Sunrise 7200 Hybrid Technology | Jk-Holding GmbH | 2019-04-08 |
| K180555 | Ergoline Prestige 1600 Hybrid Performance | Jk Holding GmbH | 2018-10-11 |
| K181455 | ProSun sunlamp products, Luxura sunlamp products | Prosun International, LLC | 2018-09-10 |
| K151721 | FIJI SUN FLUORESCENT TANNING UNIT | Kdb Inc. (Dba) Sperti Sunlamp | 2018-06-22 |
| K180581 | UV Lamps for Sunlamp Products | Feilo Sylvania Germany GmbH | 2018-06-22 |
| K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | Lpi, Inc. | 2018-04-19 |
| K173565 | Sunrise 6200, Sunrise 7200 | Jk-Holding GmbH | 2018-02-14 |
| K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | Sportarredo Group S.C. | 2017-07-06 |
| K151962 | KBL Sunlamp Products (= Device Bundling name) | Kbl AG | 2016-09-15 |
| K152405 | IBL 5000 Tanning Booth | Ibl Acquisitions, LLC | 2016-09-01 |
| K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy | Sunfire Industries, Inc. | 2016-05-20 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases