LEJ · Class II · 21 CFR 878.4635

FDA Product Code LEJ: Booth, Sun Tan

Leading manufacturers include Jk Holding GmbH and Unilam Co., Ltd..

81
Total
81
Cleared
128d
Avg days
1980
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Booth, Sun Tan Devices (Product Code LEJ)

81 devices
1–24 of 81
Cleared Feb 15, 2023
Tanning Lamp
K221523
Unilam Co., Ltd.
General & Plastic Surgery · 265d
Cleared Jul 01, 2022
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
K220500
Jk Holding GmbH
General & Plastic Surgery · 129d

About Product Code LEJ - Regulatory Context

510(k) Submission Activity

81 total 510(k) submissions under product code LEJ since 1980, with 81 receiving FDA clearance (average review time: 128 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

LEJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →