K220500 is an FDA 510(k) clearance for the 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. This device is classified as a Booth, Sun Tan (Class II - Special Controls, product code LEJ).
Submitted by Jk Holding GmbH (Windhagen, DE). The FDA issued a Cleared decision on July 1, 2022, 129 days after receiving the submission on February 22, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635.
| 510(k) Number | K220500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2022 |
| Decision Date | July 01, 2022 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LEJ - Booth, Sun Tan |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4635 |