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

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K220500 ↗

FDA Product Code

LEJ

FDA applicant

Jk-Holding GmbH

Device Class

Class II

Regulation

21 CFR Part 878.4635

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products

  Class II

  FDA 510(k) K151400 Active Cleared 16 Sep 2015

• Sunrise 6200, Sunrise 7200

  Class II

  FDA 510(k) K173565 Active Cleared 14 Feb 2018

• Ergoline Prestige 1600 Hybrid Performance

  Class II

  FDA 510(k) K180555 Active Cleared 11 Oct 2018

• Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound

  Class II

  FDA 510(k) K190173 Active Cleared 10 May 2019

• Ergoline Sunrise 7200 Hybrid Technology

  Class II

  FDA 510(k) K183539 Active Cleared 8 Apr 2019