Atlas FDA

LEJ

81 FDA 510(k) clearances · Product code

73 daysmedian time to decision
265 days90th percentile
81clearances measured

FDA profile

Official device name
Booth, Sun Tan
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4635
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 6 · 2003: 6 · 2004: 2 · 2005: 4 · 2012: 29 · 2014: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Tanning Lamp (K221523)Unilam Co., Ltd.2023-02-15
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 GmbH2022-07-01
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun (K191881)Kbl GmbH2019-10-28
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 GmbH2019-05-10
Ergoline Sunrise 7200 Hybrid Technology (K183539)Jk-Holding GmbH2019-04-08
Ergoline Prestige 1600 Hybrid Performance (K180555)Jk Holding GmbH2018-10-11
ProSun sunlamp products, Luxura sunlamp products (K181455)Prosun International, LLC2018-09-10
FIJI SUN FLUORESCENT TANNING UNIT (K151721)Kdb Inc. (Dba) Sperti Sunlamp2018-06-22
UV Lamps for Sunlamp Products (K180581)Feilo Sylvania Germany GmbH2018-06-22
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) (K180576)Lpi, Inc.2018-04-19
Sunrise 6200, Sunrise 7200 (K173565)Jk-Holding GmbH2018-02-14
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (K161394)Sportarredo Group S.C.2017-07-06
KBL Sunlamp Products (= Device Bundling name) (K151962)Kbl AG2016-09-15
IBL 5000 Tanning Booth (K152405)Ibl Acquisitions, LLC2016-09-01
Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy (K152423)Sunfire Industries, Inc.2016-05-20
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 (K152452)Medtek Lighting Corp D/B/A Peacock Tanning2016-05-19
HEX tanning booth (K152336)J & B Products Ltd Dba Hex Tanning2016-05-02
T-32;T-40;T-44;T-52;T-72;TT-50 (K152412)Tanses Technologies, Inc.2016-04-29
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS (K152364)Pc Marketing, Inc.2016-04-14
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.2016-03-04
3400E series; E5400 series; E6400 series; Sundazzler series (K151905)Heartland Tanning, Inc.2016-03-01
High Pressure Tanning Lamps (K152141)Blv Licht-Und Vakuumtechnik GmbH2016-02-25
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (K152233)Sportarredo Group S.C.2016-01-27
UV Lamps for Indoor Tanning Devices (K151370)Light Sources, Inc.2015-12-17
Suntanning Lamps (K152436)Interlectric Corporation2015-12-07
Cosmedico Ultraviolet Lamps of Various Models (K152273)Cosmedico Light, Inc.2015-10-30
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) (K152095)Cosmedico Light, Inc.2015-10-28
Ultraviolet Sun Tanning Lamp (K151674)G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh2015-10-20
Ultraviolet Sunlamps (K151841)Wolff System Technology Corp.2015-10-05
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products (K151400)Jk Holding GmbH2015-09-16
Various Brands of Ultraviolet Lamps (K150778)Cosmedico Light, Inc.2015-05-29
Tanning Lamp (K143043)Unilam Co., Ltd.2015-04-02
TANTHERA-T35 (K090831)Tanthera, Inc.2009-05-29
HARPO SUNBED, SUN TANNING MACHINE (K944015)Harpo Industries1994-09-06
ALPHA SOLAR SYSTEM TANNING BED (K943656)Heartland Tan Systems1994-08-15
ODYSSEY TAN 2000 (K936314)Fitness TO Go, Inc.1994-07-22
TAN AMERICA SUN UP (K940753)Tan America1994-04-05
CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL (K940672)Philips Lighting Co.1994-03-18
SUNDASH (K932483)Sun Ind., Inc.1994-02-22
ULTRAVIOLET LAMPS FOR TANNING (K935854)Cosmedico Light, Inc.1994-01-24
ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED (K931661)Eurocut, Ltd.1993-12-17
ULTRABRONZ SERIES 400 TANNING BED (K931660)Eurocut, Ltd.1993-12-17
SUNBRONZE TANNING LAMPS (K932418)Ess Lighting1993-12-09
FLUORESCENT T12 UVA TANNING LAMP (K923759)Quality Lamp, Inc.1993-12-09
EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 (K904644)Eurosun, Inc.1990-12-28
LIFESTYLE HOME TANNING UNITS (K901714)Life Products, Inc.1990-06-27
SUNBRONZE SB24C/65 ULTRA (K896983)Sunbronze1990-01-03
REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER (K895409)Remington Products Company, LLC1989-10-20
SUNTANNING BED (K895325)Sunbronze1989-09-15
SHAW SUN SYSTEMS MODEL 1600 (K882331)Shaw Sun Systems1988-06-22
SUN SHELL (SUN TANNING BED) (K881409)Indoor Sun Systems, Inc.1988-04-19
MTI WOLFF SYSTEM, TANNING BED (K881492)Health Systems Intl., Inc.1988-04-19
MTI WOLFF SYSTEM (K881353)Health Systems Intl., Inc.1988-04-06
ULTRA TAN PURPLE PRO (K875190)Ultra Tan Intl. AB1988-01-14
ULTRA TAN PURPLE MINT (K875189)Ultra Tan Intl. AB1988-01-14
PERFECT SUNTANNING BED (K873589)Wolff System Technology Corp.1987-10-29
K60 HABITAT ENVIRONMENT ENCLOSURE (K813208)Kohler1981-12-31
K51,K52 ENVIRONMENT ENCLOSURE (K813207)Kohler1981-12-31
FANCY TAN SUNBED (K810366)Fancy Tan, Inc.1981-03-05
SUNSCENE TANNING STUDIO (K803189)Sunscene Tanning Studio1981-01-28
SEMI-OVAL MODULAR SUNTANNING BOOTH (K802756)Tannhut1981-01-22
SUNMAKER (SUN TANNING BED) (K803090)Sunmaker, Inc.1981-01-22
SUN TANNING DEVICES (K803061)Mutzhas Corp.1981-01-13
SOLAR TONE (K802304)Bloomex International, Inc.1980-12-01
U.I. OCTOSON (K801675)Ausonics Pty , Ltd.1980-10-23
JK INT'L, INC. SOLTRON UVA TANNING BED (K802134)Mottek Intl. Corp.1980-10-23
CABANNA TAN SUNLAMP (K801925)The Marketing Exchange, Inc.1980-10-03
RAMI TAN ULTRAVIOLET B BOOTH (K801752)Rami-Tan1980-09-16
SUN VALLEY TANS (K801543)Sun Valley Tans, Inc.1980-09-16
RAMI ULTRAVIOLET A BOOTH (K801751)Rami-Tan1980-09-16
SUN ROOM TANNING BOOTH (K801674)Sun Tan Enterprises, Inc.1980-09-16
SOLAR PACIFIC UVA SUNLAMP DEVICE (K801520)Solar Pacific1980-08-20
SUNBED/SUNROOF OR SUNCOUCH/SUNSKY (K801542)Sunfit, Inc.1980-08-20
CLASSIC TAN TANNING BOOTH (K801521)Classic Tan, Inc.1980-08-20
SUNSATION (K801429)Fashion, Inc.1980-07-28
THE SUN BOOTH (K801095)Sun Booths , Ltd.1980-07-21
SUNBURST, SUN SYSTEMS OR BC2 (K801163)Sun Ray Mfg., Inc.1980-07-21
TAN YEAR ROUND SUN BED (K801341)Tan-Year Round, Inc.1980-07-21
SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1 (K800744)Sun Ind., Inc.1980-06-04
WOLFF SYSTEM (K800896)Wolff System GmbH1980-05-30
CLINICAL DATA SYSTEM (CAM) MODULE (K801029)Adac Laboratories1980-05-28

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Every clearance here is in the API, with alerts when new ones post.