LEJ · Class II · 21 CFR 878.4635

FDA Product Code LEJ: Booth, Sun Tan

Leading manufacturers include Jk Holding GmbH, Kdb Inc. (Dba) Sperti Sunlamp and Lpi, Inc..

81
Total
81
Cleared
128d
Avg days
1980
Since
Declining activity - 0 submissions in the last 2 years vs 1 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
Cleared Oct 28, 2019
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
K191881
Kbl GmbH
General & Plastic Surgery · 105d
Cleared May 10, 2019
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
K190173
Jk Holding GmbH
General & Plastic Surgery · 98d
Cleared Apr 08, 2019
Ergoline Sunrise 7200 Hybrid Technology
K183539
Jk Holding GmbH
General & Plastic Surgery · 109d
Cleared Oct 11, 2018
Ergoline Prestige 1600 Hybrid Performance
K180555
Jk Holding GmbH
General & Plastic Surgery · 224d
Cleared Sep 10, 2018
ProSun sunlamp products, Luxura sunlamp products
K181455
Prosun International, LLC
General & Plastic Surgery · 98d
Cleared Jun 22, 2018
FIJI SUN FLUORESCENT TANNING UNIT
K151721
Kdb Inc. (Dba) Sperti Sunlamp
General & Plastic Surgery · 1093d
Cleared Jun 22, 2018
UV Lamps for Sunlamp Products
K180581
Feilo Sylvania Germany GmbH
General & Plastic Surgery · 113d
Cleared Apr 19, 2018
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
K180576
Lpi, Inc.
General & Plastic Surgery · 45d
Cleared Feb 14, 2018
Sunrise 6200, Sunrise 7200
K173565
Jk Holding GmbH
General & Plastic Surgery · 89d

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 1 in the prior period.