Product Code: LEJ FDA class 2 21 CFR 878.4635

Booth, Sun Tan

General, Plastic Surgery

A sun tan booth is a device that uses ultraviolet light sources to artificially tan the skin, regulated by the FDA as a device in the General, Plastic Surgery specialty with moderate risk considerations. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is LEJ, regulated under 21 CFR 878.4635, in the General, Plastic Surgery specialty. Third-party review eligibility applies.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: LEJ
Device Class: FDA class 2
Regulation Number: 878.4635
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 81 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K221523	Tanning Lamp	Feb 15, 2023	Substantially Equivalent	Unilam Co., Ltd.
K220500	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	Jul 01, 2022	Substantially Equivalent	Jk-Holding GmbH
K191881	KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun	Oct 28, 2019	Substantially Equivalent	Kbl GmbH
K190173	Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound	May 10, 2019	Substantially Equivalent	Jk-Holding GmbH
K183539	Ergoline Sunrise 7200 Hybrid Technology	Apr 08, 2019	Substantially Equivalent	Jk-Holding GmbH
K180555	Ergoline Prestige 1600 Hybrid Performance	Oct 11, 2018	Substantially Equivalent	Jk Holding GmbH
K181455	ProSun sunlamp products, Luxura sunlamp products	Sep 10, 2018	Substantially Equivalent	Prosun International, LLC
K180581	UV Lamps for Sunlamp Products	Jun 22, 2018	Substantially Equivalent	Feilo Sylvania Germany GmbH
K151721	FIJI SUN FLUORESCENT TANNING UNIT	Jun 22, 2018	Substantially Equivalent	Kdb Inc. (Dba) Sperti Sunlamp
K180576	Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)	Apr 19, 2018	Substantially Equivalent	Lpi, Inc.
K173565	Sunrise 6200, Sunrise 7200	Feb 14, 2018	Substantially Equivalent	Jk-Holding GmbH
K161394	HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux	Jul 06, 2017	Substantially Equivalent	Sportarredo Group S.C.
K151962	KBL Sunlamp Products (= Device Bundling name)	Sep 15, 2016	Substantially Equivalent	Kbl AG
K152405	IBL 5000 Tanning Booth	Sep 01, 2016	Substantially Equivalent	Ibl Acquisitions, LLC
K152423	Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy	May 20, 2016	Substantially Equivalent	Sunfire Industries, Inc.
K152452	Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200	May 19, 2016	Substantially Equivalent	Medtek Lighting Corp D/B/A Peacock Tanning
K152336	HEX tanning booth	May 02, 2016	Substantially Equivalent	J & B Products Ltd Dba Hex Tanning
K152412	T-32;T-40;T-44;T-52;T-72;TT-50	Apr 29, 2016	Substantially Equivalent	Tanses Technologies, Inc.
K152364	uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS	Apr 14, 2016	Substantially Equivalent	Pc Marketing, Inc.
K152238	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	Mar 04, 2016	Substantially Equivalent	Sun Capsule, Inc.
K151905	3400E series; E5400 series; E6400 series; Sundazzler series	Mar 01, 2016	Substantially Equivalent	Heartland Tanning, Inc.
K152141	High Pressure Tanning Lamps	Feb 25, 2016	Substantially Equivalent	Blv Licht-Und Vakuumtechnik GmbH
K152233	BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux	Jan 27, 2016	Substantially Equivalent	Sportarredo Group S.C.
K151370	UV Lamps for Indoor Tanning Devices	Dec 17, 2015	Substantially Equivalent	Light Sources, Inc.
K152436	Suntanning Lamps	Dec 07, 2015	Substantially Equivalent	Interlectric Corporation
K152273	Cosmedico Ultraviolet Lamps of Various Models	Oct 30, 2015	Substantially Equivalent	Cosmedico Light, Inc.
K152095	Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)	Oct 28, 2015	Substantially Equivalent	Cosmedico Light, Inc.
K151674	Ultraviolet Sun Tanning Lamp	Oct 20, 2015	Substantially Equivalent	G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh
K151841	Ultraviolet Sunlamps	Oct 05, 2015	Substantially Equivalent	Wolff System Technology Corp.
K151400	Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products	Sep 16, 2015	Substantially Equivalent	Jk Holding GmbH
K150778	Various Brands of Ultraviolet Lamps	May 29, 2015	Substantially Equivalent	Cosmedico Light, Inc.
K143043	Tanning Lamp	Apr 02, 2015	Substantially Equivalent	Unilam Co., Ltd.
K090831	TANTHERA-T35	May 29, 2009	Substantially Equivalent	Tanthera, Inc.
K944015	HARPO SUNBED, SUN TANNING MACHINE	Sep 06, 1994	Substantially Equivalent	Harpo Industries
K943656	ALPHA SOLAR SYSTEM TANNING BED	Aug 15, 1994	Substantially Equivalent	Heartland Tan Systems
K936314	ODYSSEY TAN 2000	Jul 22, 1994	Substantially Equivalent	Fitness TO Go, Inc.
K940753	TAN AMERICA SUN UP	Apr 05, 1994	Substantially Equivalent	Tan America
K940672	CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL	Mar 18, 1994	Substantially Equivalent	Philips Lighting Co.
K932483	SUNDASH	Feb 22, 1994	Substantially Equivalent	Sun Ind., Inc.
K935854	ULTRAVIOLET LAMPS FOR TANNING	Jan 24, 1994	Substantially Equivalent	Cosmedico Light, Inc.
K931661	ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED	Dec 17, 1993	Substantially Equivalent	Eurocut, Ltd.
K931660	ULTRABRONZ SERIES 400 TANNING BED	Dec 17, 1993	Substantially Equivalent	Eurocut, Ltd.
K932418	SUNBRONZE TANNING LAMPS	Dec 09, 1993	Substantially Equivalent	Ess Lighting
K923759	FLUORESCENT T12 UVA TANNING LAMP	Dec 09, 1993	Substantially Equivalent	Quality Lamp, Inc.
K904644	EUROSUN MODELS - ES-2400, ES-VHO AND ES-16	Dec 28, 1990	Substantially Equivalent	Eurosun, Inc.
K901714	LIFESTYLE HOME TANNING UNITS	Jun 27, 1990	Substantially Equivalent	Life Products, Inc.
K896983	SUNBRONZE SB24C/65 ULTRA	Jan 03, 1990	Substantially Equivalent	Sunbronze
K895409	REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER	Oct 20, 1989	Substantially Equivalent	Remington Products Company, LLC
K895325	SUNTANNING BED	Sep 15, 1989	Substantially Equivalent	Sunbronze
K882331	SHAW SUN SYSTEMS MODEL 1600	Jun 22, 1988	Substantially Equivalent	Shaw Sun Systems
K881492	MTI WOLFF SYSTEM, TANNING BED	Apr 19, 1988	Substantially Equivalent	Health Systems Intl., Inc.
K881409	SUN SHELL (SUN TANNING BED)	Apr 19, 1988	Substantially Equivalent	Indoor Sun Systems, Inc.
K881353	MTI WOLFF SYSTEM	Apr 06, 1988	Substantially Equivalent	Health Systems Intl., Inc.
K875190	ULTRA TAN PURPLE PRO	Jan 14, 1988	Substantially Equivalent	Ultra Tan Intl. AB
K875189	ULTRA TAN PURPLE MINT	Jan 14, 1988	Substantially Equivalent	Ultra Tan Intl. AB
K873589	PERFECT SUNTANNING BED	Oct 29, 1987	Substantially Equivalent	Wolff System Technology Corp.
K813208	K60 HABITAT ENVIRONMENT ENCLOSURE	Dec 31, 1981	Substantially Equivalent	Kohler
K813207	K51,K52 ENVIRONMENT ENCLOSURE	Dec 31, 1981	Substantially Equivalent	Kohler
K810366	FANCY TAN SUNBED	Mar 05, 1981	Substantially Equivalent	Fancy Tan, Inc.
K803189	SUNSCENE TANNING STUDIO	Jan 28, 1981	Substantially Equivalent	Sunscene Tanning Studio
K803090	SUNMAKER (SUN TANNING BED)	Jan 22, 1981	Substantially Equivalent	Sunmaker, Inc.
K802756	SEMI-OVAL MODULAR SUNTANNING BOOTH	Jan 22, 1981	Substantially Equivalent	Tannhut
K803061	SUN TANNING DEVICES	Jan 13, 1981	Substantially Equivalent	Mutzhas Corp.
K802304	SOLAR TONE	Dec 01, 1980	Substantially Equivalent	Bloomex International, Inc.
K802134	JK INT'L, INC. SOLTRON UVA TANNING BED	Oct 23, 1980	Substantially Equivalent	Mottek Intl. Corp.
K801675	U.I. OCTOSON	Oct 23, 1980	Substantially Equivalent	Ausonics Pty , Ltd.
K801925	CABANNA TAN SUNLAMP	Oct 03, 1980	Substantially Equivalent	The Marketing Exchange, Inc.
K801752	RAMI TAN ULTRAVIOLET B BOOTH	Sep 16, 1980	Substantially Equivalent	Rami-Tan
K801751	RAMI ULTRAVIOLET A BOOTH	Sep 16, 1980	Substantially Equivalent	Rami-Tan
K801674	SUN ROOM TANNING BOOTH	Sep 16, 1980	Substantially Equivalent	Sun Tan Enterprises, Inc.
K801543	SUN VALLEY TANS	Sep 16, 1980	Substantially Equivalent	Sun Valley Tans, Inc.
K801542	SUNBED/SUNROOF OR SUNCOUCH/SUNSKY	Aug 20, 1980	Substantially Equivalent	Sunfit, Inc.
K801521	CLASSIC TAN TANNING BOOTH	Aug 20, 1980	Substantially Equivalent	Classic Tan, Inc.
K801520	SOLAR PACIFIC UVA SUNLAMP DEVICE	Aug 20, 1980	Substantially Equivalent	Solar Pacific
K801429	SUNSATION	Jul 28, 1980	Substantially Equivalent	Fashion, Inc.
K801341	TAN YEAR ROUND SUN BED	Jul 21, 1980	Substantially Equivalent	Tan-Year Round, Inc.
K801163	SUNBURST, SUN SYSTEMS OR BC2	Jul 21, 1980	Substantially Equivalent	Sun Ray Mfg., Inc.
K801095	THE SUN BOOTH	Jul 21, 1980	Substantially Equivalent	Sun Booths , Ltd.
K800744	SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1	Jun 04, 1980	Substantially Equivalent	Sun Ind., Inc.
K800896	WOLFF SYSTEM	May 30, 1980	Substantially Equivalent	Wolff System GmbH
K801029	CLINICAL DATA SYSTEM (CAM) MODULE	May 28, 1980	Substantially Equivalent	Adac Laboratories