Home / 510(k) Clearances / K190173

510(k) K190173

Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound by Jk-Holding GmbH — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2019
Date Received
February 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Booth, Sun Tan
Device Class
Class II
Regulation Number
878.4635
Review Panel
SU
Submission Type

Other clearances by Jk-Holding GmbH

  • K220500 — Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fit (July 1, 2022)
  • K183539 — Ergoline Sunrise 7200 Hybrid Technology (April 8, 2019)
  • K173565 — Sunrise 6200, Sunrise 7200 (February 14, 2018)

Other clearances for product code LEJ

  • K221523 — Tanning Lamp (February 15, 2023)
  • K220500 — Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fit (July 1, 2022)
  • K191881 — KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun (October 28, 2019)
  • K183539 — Ergoline Sunrise 7200 Hybrid Technology (April 8, 2019)
  • K180555 — Ergoline Prestige 1600 Hybrid Performance (October 11, 2018)
  • K181455 — ProSun sunlamp products, Luxura sunlamp products (September 10, 2018)
  • K151721 — FIJI SUN FLUORESCENT TANNING UNIT (June 22, 2018)
  • K180581 — UV Lamps for Sunlamp Products (June 22, 2018)
  • K180576 — Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite an (April 19, 2018)
  • K173565 — Sunrise 6200, Sunrise 7200 (February 14, 2018)