LEJ — Booth, Sun Tan Class II
FDA product code LEJ covers "Booth, Sun Tan", a Class II medical device regulated under 21 CFR 878.4635. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- LEJ
- Device Class
- Class II
- Regulation Number
- 878.4635
- Submission Type
- 510(k)
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221523 | Unilam Co | Tanning Lamp | Feb 15, 2023 |
| K220500 | Jk-Holding | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet… | Jul 1, 2022 |
| K191881 | Kbl | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | Oct 28, 2019 |
| K190173 | Jk-Holding | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550… | May 10, 2019 |
| K183539 | Jk-Holding | Ergoline Sunrise 7200 Hybrid Technology | Apr 8, 2019 |
| K180555 | Jk Holding | Ergoline Prestige 1600 Hybrid Performance | Oct 11, 2018 |
| K181455 | Prosun International | ProSun sunlamp products, Luxura sunlamp products | Sep 10, 2018 |
| K180581 | Feilo Sylvania Germany | UV Lamps for Sunlamp Products | Jun 22, 2018 |
| K151721 | Kdb Inc. (Dba) Sperti Sunlamp | FIJI SUN FLUORESCENT TANNING UNIT | Jun 22, 2018 |
| K180576 | Lpi | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite… | Apr 19, 2018 |
| K173565 | Jk-Holding | Sunrise 6200, Sunrise 7200 | Feb 14, 2018 |
| K161394 | Sportarredo Group S.C | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | Jul 6, 2017 |
| K151962 | Kbl | KBL Sunlamp Products (= Device Bundling name) | Sep 15, 2016 |
| K152405 | Ibl Acquisitions | IBL 5000 Tanning Booth | Sep 1, 2016 |
| K152423 | Sunfire Industries | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy… | May 20, 2016 |
| K152452 | Medtek Lighting Corp D/B/A Peacock Tanning | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 | May 19, 2016 |
| K152336 | J And B Products Ltd Dba Hex Tanning | HEX tanning booth | May 2, 2016 |
| K152412 | Tanses Technologies | T-32;T-40;T-44;T-52;T-72;TT-50 | Apr 29, 2016 |
| K152364 | Pc Marketing | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS | Apr 14, 2016 |
| K152238 | Sun Capsule | Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6… | Mar 4, 2016 |