FDA Product Code LEJ: Booth, Sun Tan
Leading manufacturers include Jk Holding GmbH, Cosmedico Light, Inc. and Unilam Co., Ltd..
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
Cleared
Feb 15, 2023
Tanning Lamp
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
Jk Holding GmbH
General & Plastic Surgery
129d
Cleared
Oct 28, 2019
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
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
Jk Holding GmbH
General & Plastic Surgery
98d
Cleared
Apr 08, 2019
Ergoline Sunrise 7200 Hybrid Technology
Jk Holding GmbH
General & Plastic Surgery
109d
Cleared
Oct 11, 2018
Ergoline Prestige 1600 Hybrid Performance
Jk Holding GmbH
General & Plastic Surgery
224d
Cleared
Sep 10, 2018
ProSun sunlamp products, Luxura sunlamp products
Prosun International, LLC
General & Plastic Surgery
98d
Cleared
Jun 22, 2018
FIJI SUN FLUORESCENT TANNING UNIT
Kdb Inc. (Dba) Sperti Sunlamp
General & Plastic Surgery
1093d
Cleared
Jun 22, 2018
UV Lamps for Sunlamp Products
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)
Lpi, Inc.
General & Plastic Surgery
45d
Cleared
Feb 14, 2018
Sunrise 6200, Sunrise 7200
Jk Holding GmbH
General & Plastic Surgery
89d
Cleared
Jul 06, 2017
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Sportarredo Group S.C.
General & Plastic Surgery
413d
Cleared
Sep 15, 2016
KBL Sunlamp Products (= Device Bundling name)
Kbl AG
General & Plastic Surgery
427d
Cleared
Sep 01, 2016
IBL 5000 Tanning Booth
Ibl Acquisitions, LLC
General & Plastic Surgery
373d
Cleared
May 20, 2016
Sunfire 32 Tanning Bed
Sunfire Industries, Inc.
General & Plastic Surgery
268d
Cleared
May 19, 2016
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
Medtek Lighting Corp D/B/A Peacock Tanning
General & Plastic Surgery
265d
Cleared
May 02, 2016
HEX tanning booth
J & B Products Ltd Dba Hex Tanning
General & Plastic Surgery
257d
Cleared
Apr 29, 2016
T-32
Tanses Technologies, Inc.
General & Plastic Surgery
247d
Cleared
Apr 14, 2016
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
Pc Marketing, Inc.
General & Plastic Surgery
237d
Cleared
Mar 04, 2016
Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
Sun Capsule, Inc.
General & Plastic Surgery
207d
Cleared
Mar 01, 2016
3400E series
Heartland Tanning, Inc.
General & Plastic Surgery
232d
Cleared
Feb 25, 2016
High Pressure Tanning Lamps
Blv Licht-Und Vakuumtechnik GmbH
General & Plastic Surgery
206d
Cleared
Jan 27, 2016
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Sportarredo Group S.C.
General & Plastic Surgery
173d
Cleared
Dec 17, 2015
UV Lamps for Indoor Tanning Devices
Light Sources, Inc.
General & Plastic Surgery
210d
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.