LEJ · Class II · 21 CFR 878.4635

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
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
Cleared Jul 06, 2017
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
K161394
Sportarredo Group S.C.
General & Plastic Surgery · 413d
Cleared Sep 15, 2016
KBL Sunlamp Products (= Device Bundling name)
K151962
Kbl AG
General & Plastic Surgery · 427d
Cleared Sep 01, 2016
IBL 5000 Tanning Booth
K152405
Ibl Acquisitions, LLC
General & Plastic Surgery · 373d
Cleared May 20, 2016
Sunfire 32 Tanning Bed
K152423
Sunfire Industries, Inc.
General & Plastic Surgery · 268d
Cleared May 19, 2016
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
K152452
Medtek Lighting Corp D/B/A Peacock Tanning
General & Plastic Surgery · 265d
Cleared May 02, 2016
HEX tanning booth
K152336
J & B Products Ltd Dba Hex Tanning
General & Plastic Surgery · 257d
Cleared Apr 29, 2016
T-32
K152412
Tanses Technologies, Inc.
General & Plastic Surgery · 247d
Cleared Apr 14, 2016
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
K152364
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
K152238
Sun Capsule, Inc.
General & Plastic Surgery · 207d
Cleared Mar 01, 2016
3400E series
K151905
Heartland Tanning, Inc.
General & Plastic Surgery · 232d
Cleared Feb 25, 2016
High Pressure Tanning Lamps
K152141
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
K152233
Sportarredo Group S.C.
General & Plastic Surgery · 173d
Cleared Dec 17, 2015
UV Lamps for Indoor Tanning Devices
K151370
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.