# 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

- Pathway: 510(k) (Traditional)
- Applicant: Jk-Holding GmbH
- Decided: Jul 1, 2022 after 129 days
- Product code: LEJ (Booth, Sun Tan)
- Device class: 2
- Regulation: 21 CFR 878.4635
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K151400 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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) Summary page 9.
- K151400: Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products, Jk Holding GmbH (2015) Summary page 17.
- K180555: Ergoline Prestige 1600 Hybrid Performance, Jk Holding GmbH (2018) Summary page 21.

## Indications for use
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.

Source page: https://510kreport.com/device/K220500
Methodology: https://510kreport.com/methodology