Product Code: FTC FDA class 2 21 CFR 878.4630

Light, Ultraviolet, Dermatological

General, Plastic Surgery

A dermatological ultraviolet light is a device that emits ultraviolet radiation for therapeutic purposes, used in the treatment of skin conditions such as psoriasis, vitiligo, and other photosensitive dermatological disorders. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FTC, regulated under 21 CFR 878.4630, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

272

FEI Numbers

Registration Numbers

Unique Applicants

150

Years Active

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Basic Information

Product Code: FTC
Device Class: FDA class 2
Regulation Number: 878.4630
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 272 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254234	Phototherapy System (DUV-COMBO)	May 01, 2026	Substantially Equivalent	Choyang Medics Co., Ltd.
K253871	Klär Lite (RCW-KL1000)	Mar 04, 2026	Substantially Equivalent	Radcliffe Watts, LLC
K250425	Ultraviolet Phototherapy Device	Apr 07, 2025	Substantially Equivalent	APK Technology Co., Ltd.
K244022	308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)	Mar 13, 2025	Substantially Equivalent	Boston Aesthetics, Inc.
K242977	308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)	Feb 06, 2025	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.
K242908	UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)	Dec 19, 2024	Substantially Equivalent	Shanghai Sigma High-Tech Co., Ltd.
K233811	DT Controlled Phototherapy Equipment	Dec 13, 2023	Substantially Equivalent	Daavlin Distributing Co.
K223882	Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)	Mar 27, 2023	Substantially Equivalent	Shenzhen Honpal Optoelectronic Technology Co., Ltd.
K230382	3 Series NeoLux	Mar 24, 2023	Substantially Equivalent	Daavlin Distributing Co.
K230076	Enhanced AURORA Medical Diode System, and related accessories	Mar 08, 2023	Substantially Equivalent	Psoria-Shield, Inc.
K220840	1 Series Phototherapy Equipment	Apr 22, 2022	Substantially Equivalent	Daavlin Distributing Co.
K210004	i8 Tanning Booth	Dec 10, 2021	Substantially Equivalent	Ultrasun International B.V.
K212510	7 Series Phototherapy Device	Nov 04, 2021	Substantially Equivalent	Daavlin Distributing Co.
K210881	M Series Phototherapy Equipment	Jun 22, 2021	Substantially Equivalent	Daavlin Distributing Co.
K202827	308nm Excimer UV-light Skin Therapy System	Dec 15, 2020	Substantially Equivalent	Shenzhen Gsd Tech Co., Ltd.
K200971	308nm Excimer System	Dec 15, 2020	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.
K192411	Psoria-Shield AURORA	Jul 02, 2020	Substantially Equivalent	Psoria-Shield
K192642	308nm Excimer System	May 13, 2020	Substantially Equivalent	Chongqing Peninsula Medical Technology Co., Ltd.
K191571	UV Radiation Treatment System	Feb 06, 2020	Substantially Equivalent	Xuzhou Yongkang Electronic Science Technology Co., Ltd.
K191086	Exciplex	Dec 11, 2019	Substantially Equivalent	Clarteis
K181805	UV Phototherapy	Jan 11, 2019	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.
K182215	ClearLink Controlled Phototherapy Equipment	Oct 29, 2018	Substantially Equivalent	Daavlin Distributing Company
K172273	308nm Excimer System	Jul 30, 2018	Substantially Equivalent	Chongqing Peninsula Medical Technology Co., Ltd.
K173436	Luma Light System	Jan 30, 2018	Substantially Equivalent	Luma Therapeutics
K171702	Exciplex308nm	Oct 13, 2017	Substantially Equivalent	Clarteis
K170489	Skylit Phototherapy System	May 23, 2017	Substantially Equivalent	Skylit Medical
K153749	3 Series Phototherapy Unit	Jun 30, 2016	Substantially Equivalent	Daavlin Distributing Company
K151795	ML24000 UVA-1 Phototherapy Cabinet	Sep 10, 2015	Substantially Equivalent	Daavlin Distributing Co.
K150752	GME ExSys 308	Jul 31, 2015	Substantially Equivalent	Gme (German Medical Engineering) GmbH
K150912	Houva-NET Control System	Jul 10, 2015	Substantially Equivalent	National Biological Corporation
K134009	UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL	Oct 15, 2014	Substantially Equivalent	Medtek Lighting
K132643	UV PHOTOTHERAPY	Jan 30, 2014	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.
K130519	PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS	Dec 24, 2013	Substantially Equivalent	Philips Lighting Company
K111049	MOBILE VERSA LIGHT	May 25, 2012	Substantially Equivalent	Medtek Lighting Corp
K110912	SMART TOUCH UVTHERAPY MULTIPLE MACHINE	Oct 20, 2011	Substantially Equivalent	Daavlin Distributing Co.
K111172	4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES	Aug 29, 2011	Substantially Equivalent	Daavlin Distributing Co.
K103204	SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY	Apr 27, 2011	Substantially Equivalent	Solarc Systems, Inc.
K103708	ML24000 UVA-1 PHOTOTHERAPY UNIT	Feb 22, 2011	Substantially Equivalent	The Daavlin Distributing Company
K103540	PSORIA-LIGHT	Feb 10, 2011	Substantially Equivalent	Psoria-Shield, Inc.
K100378	1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4	Apr 28, 2010	Substantially Equivalent	Daavlin Distributing Co.
K091568	LH-75 PHOTOTHERAPY SYSTEM	Nov 05, 2009	Substantially Equivalent	Lerner Medical Devices, Inc.
K090097	LH-75T PHOTOTHERAPY SYSTEM	Feb 26, 2009	Substantially Equivalent	Lerner Medical Devices, Inc.
K082731	ML24000 UVA-1 PHOTOTHERAPY CABINET	Dec 17, 2008	Substantially Equivalent	Daavlin Distributing Co.
K073503	VERSA LITE	Jan 23, 2008	Substantially Equivalent	Diomedics, Inc.
K073587	DERMAPAL WITH DIGITAL TIMER	Jan 18, 2008	Substantially Equivalent	Daavlin Distributing Co.
K073066	308 DERMATOLOGICAL EXCIMER SYSTEM	Dec 26, 2007	Substantially Equivalent	Quantel Medical, Inc.
K072035	RESOLVE UVB PHOTOTHERAPY SYSTEM	Oct 16, 2007	Substantially Equivalent	Allux Medical
K070934	PANOSOL II TRU-BLU, MODEL UBL-417	May 22, 2007	Substantially Equivalent	National Biological Corp.
K063621	3 SERIES PHOTOTHERAPY CABINET	Jan 17, 2007	Substantially Equivalent	Daavlin Co.
K061589	SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY	Aug 04, 2006	Substantially Equivalent	Solarc Systems, Inc.
K061295	VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100	May 25, 2006	Substantially Equivalent	Theralight, Inc.
K051330	UVBIOTEK MODELS 3200B AND 4000B	Nov 18, 2005	Substantially Equivalent	Medtek Lighting Corporation
K052660	MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO	Oct 17, 2005	Substantially Equivalent	The Richmond Light Co.
K050080	CYNOSUREA ECLILITE AND ECLILITE U	May 05, 2005	Substantially Equivalent	Cynosure, Inc.
K050695	FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT	Apr 19, 2005	Substantially Equivalent	Daavlin Distributing Co.
K042502	3 SERIES PHOTOTHERAPY CABINET	Oct 14, 2004	Substantially Equivalent	Daavlin Distributing Co.
K041212	HOUVA 3 PHOTOTHERAPY SYSTEM	Jun 09, 2004	Substantially Equivalent	National Biological Corp.
K033946	LOVELY SYSTEM	Apr 05, 2004	Substantially Equivalent	Msq (M2) , Ltd.
K040062	LEVIA PHOTOTHERAPY SYSTEM	Feb 13, 2004	Substantially Equivalent	Lerner Medical Devices, Inc.
K031800	SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:	Sep 10, 2003	Substantially Equivalent	Solarc Systems, Inc.
K024020	THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM	Jan 17, 2003	Substantially Equivalent	Theralight, Inc.
K022104	DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ	Sep 10, 2002	Substantially Equivalent	Daavlin Distributing Co.
K021762	BCLEAR	Aug 23, 2002	Substantially Equivalent	Lumenis, Inc.
K022165	THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2	Jul 18, 2002	Substantially Equivalent	Theralight, Inc.
K021514	PHILIPS PLS9W/12/2P UVB	May 16, 2002	Substantially Equivalent	Philips Lighting Co.
K021092	PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B	May 16, 2002	Substantially Equivalent	Philips Lighting Co.
K020591	BCLEAR	May 16, 2002	Substantially Equivalent	Lumenis
K011197	DERMACLEAR UV-B PHOTOTHERAPY SYSTEM	Dec 14, 2001	Substantially Equivalent	Lumenis
K982082	HANDISOL WOUND HEALING	Oct 28, 1998	Substantially Equivalent	National Biological Corp.
K935525	PHOTOTHERAPEUTIX MODEL 2480AB	May 19, 1995	Substantially Equivalent	Avex Industries , Ltd.
K933954	PHOTOTHERAPEUTIX MODEL 2400B	Feb 21, 1995	Substantially Equivalent	Avex Industries , Ltd.
K933953	PHOTOTHERAPEUTIX MODEL 1650B	Feb 21, 1995	Substantially Equivalent	Avex Industries , Ltd.
K933952	PHOTOTHERAPEUTIX MODEL 800B	Feb 21, 1995	Substantially Equivalent	Avex Industries , Ltd.
K935526	PHOTOTHERAPEUTIX MODEL 1600B	Feb 17, 1995	Substantially Equivalent	Avex Industries , Ltd.
K935524	PHOTOTHERAPEUTIX MODEL 3200A	Feb 17, 1995	Substantially Equivalent	Avex Industries , Ltd.
K935572	SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT	Mar 07, 1994	Substantially Equivalent	Solarc Systems, Inc.
K935840	TL 20W/12/RS & TL 40W/12/RS	Feb 24, 1994	Substantially Equivalent	Philips Lighting Co.
K934808	UVISOL AND UVISOL II	Dec 16, 1993	Substantially Equivalent	National Biological Corp.
K933146	ESB 2400 SEI	Sep 23, 1993	Substantially Equivalent	Esb, Inc., Div. of Ray-O-Vac
K930856	PSORALITE	Aug 26, 1993	Substantially Equivalent	Daavlin Co.
K924969	PHOTOTHERAPY TIMER	Feb 23, 1993	Substantially Equivalent	National Biological Corp.
K925171	FREE SUN PRO DESIGN 3000 AND 3800	Dec 29, 1992	Substantially Equivalent	Free Sun Prod. AB
K924077	HANDISOL	Nov 20, 1992	Substantially Equivalent	National Biological Corp.
K922963	TL100W/12	Sep 02, 1992	Substantially Equivalent	Philips Lighting Co.
K915426	MEDICAL SUNLAMP FOR PHOTOTHERAPY	Mar 04, 1992	Substantially Equivalent	American Sunlight, Inc.
K913760	PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT	Oct 28, 1991	Substantially Equivalent	Psoralite Corp.
K910767	TL100W/01 UVB LAMP	May 23, 1991	Substantially Equivalent	Philips Lighting Co.
K904428	PANOSOL II UAB-228	Dec 24, 1990	Substantially Equivalent	National Biological Corp.
K904427	PANOSOL II UVB-206	Dec 24, 1990	Substantially Equivalent	National Biological Corp.
K904426	PANOSOL II UVA-218	Dec 24, 1990	Substantially Equivalent	National Biological Corp.
K904425	MODEL 6/01 UV-B FIXTURE	Nov 21, 1990	Substantially Equivalent	Strato-Ray Co.
K901324	U.V. SUNLAMP 95UF-II	Apr 26, 1990	Substantially Equivalent	Light Sources, Inc.
K900649	FLUORESCENT T12 UVA LAMP	Mar 28, 1990	Substantially Equivalent	Light Sources, Inc.
K900693	U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)	Mar 27, 1990	Substantially Equivalent	Light Sources, Inc.
K896831	ALISUN SUNTANNING BED	Dec 27, 1989	Substantially Equivalent	Alisun America, Ltd.
K896191	SUNTANNING BED, INC. T12 UVA TANNING LAMPS	Dec 27, 1989	Substantially Equivalent	Sunbronze
K895410	REMINGTON TANFASTIC HANDHELD TANNING WAND	Nov 27, 1989	Substantially Equivalent	Remington Products Company, LLC
K885029	HOUVA II UVA/UVB	Jun 02, 1989	Substantially Equivalent	National Biological Corp.
K885026	HOUVA II UVB	Jun 02, 1989	Substantially Equivalent	National Biological Corp.
K890084	PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000	May 11, 1989	Unknown	Psoralite Corp.
K885184	SHAW SUN SYSTEMS MODEL 2400	Jan 09, 1989	Substantially Equivalent	Shaw Sun Systems
K885025	HOUVA II UVA	Jan 09, 1989	Substantially Equivalent	National Biological Corp.
K883929	TANNING BED	Oct 03, 1988	Substantially Equivalent	Dallas Tan, Inc.
K883952	U. V. SUNLAMP 95UF-11	Sep 28, 1988	Substantially Equivalent	Light Sources, Inc.
K882722	HOUVA-BED	Aug 30, 1988	Substantially Equivalent	National Biological Corp.
K881923	ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72	Jul 07, 1988	Substantially Equivalent	Ultraviolet Resources Intl.
K881385	PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL	Apr 13, 1988	Substantially Equivalent	Psoralite Corp.
K874889	U.V. SUNLAMP 95 UF-11	Dec 30, 1987	Substantially Equivalent	Light Sources, Inc.
K873430	FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12	Sep 25, 1987	Substantially Equivalent	Klafs Sunlight Corp.
K872648	SOLAR GOLD UVA SUN TANNING BED	Aug 04, 1987	Substantially Equivalent	An-Mar International, Ltd.
K872707	PANOSOL 2000 624-404	Jul 27, 1987	Substantially Equivalent	National Biological Corp.
K872706	PANOSOL 2000 624-616	Jul 27, 1987	Substantially Equivalent	National Biological Corp.
K872651	PANOSOL 2000 624-414	Jul 27, 1987	Substantially Equivalent	National Biological Corp.
K872650	PANOSOL 2000 624-604	Jul 27, 1987	Substantially Equivalent	National Biological Corp.
K872649	HAND/FOOT UVA/UVB 624-224	Jul 27, 1987	Substantially Equivalent	National Biological Corp.
K872605	HAND/FOOT UVA 624-218	Jul 24, 1987	Substantially Equivalent	National Biological Corp.
K872604	HAND/FOOT 624-208	Jul 24, 1987	Substantially Equivalent	National Biological Corp.
K871237	SUN CAPSULE I & II SUNTANNING BOOTH	Apr 23, 1987	Substantially Equivalent	Sun Capsule, Inc.
K870167	U.V. SUNLAMP 95UF-11	Feb 09, 1987	Substantially Equivalent	Light Sources, Inc.
K864511	PSORALITE 18400 SERIES	Feb 04, 1987	Substantially Equivalent	Psoralite Corp.
K864510	PSORALITE 12800 SERIES	Feb 04, 1987	Substantially Equivalent	Psoralite Corp.
K864546	MAXI-TAN DEVICE	Jan 09, 1987	Substantially Equivalent	National Biological Corp.
K864907	SUNTANNING LAMP	Jan 05, 1987	Substantially Equivalent	Interlectric Corp.
K864485	SUNFIT SUNLAMP	Dec 17, 1986	Substantially Equivalent	Sunfit, Inc.
K863937	OSRAM ULTRAMED 400 W	Nov 04, 1986	Substantially Equivalent for Some Indications	Osram GmbH
K863555	BREMI BEAUTY BRONZE	Oct 02, 1986	Substantially Equivalent	Handelsonderneming Bremi B.V.
K863518	WEINGART MODEL 1000 SUNLAMP PRODUCT	Oct 02, 1986	Substantially Equivalent	Weingart, Inc.
K862608	SPERTILITE PHOTOTHERAPY LAMP	Aug 06, 1986	Substantially Equivalent for Some Indications	Cooper-Hewitt Electric Co.
K862372	ULTRATAN TANNING SYSTEM	Jul 09, 1986	Substantially Equivalent	Health Systems Intl., Inc.
K862341	TANNING SOFA	Jul 09, 1986	Substantially Equivalent	Hardwood Design Shop
K861963	ULTRALITE HF1236 HAND AND FOOT SYSTEM	Jun 25, 1986	Substantially Equivalent	Ultralite
K862263	PERSUNAL TAN, MODEL NO. HU-0208L	Jun 20, 1986	Substantially Equivalent	Sunthetic Engineering, Inc.
K862142	SUN-DREAMER SUNTANNING BED	Jun 17, 1986	Substantially Equivalent	Sun-Dream Tanning , Ltd.
K862097	FACE TANNER	Jun 17, 1986	Substantially Equivalent	Tan America Mfg.
K861989	MODIFICATION OF SUNTANA SUN SYSTEM BED	Jun 09, 1986	Substantially Equivalent	Hawaiian Tan Spa
K861705	CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP)	May 16, 1986	Substantially Equivalent	Vita-Tan Corp.
K861636	MIAMI-SUNNY	May 16, 1986	Substantially Equivalent	Sunworld Corp.
K861570	ALPHA TAN 1000 AND ALPHA TAN 1200	May 13, 1986	Substantially Equivalent	Midwest Marketing Service
K861447	ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900	May 13, 1986	Substantially Equivalent	Southern Exposure, Inc.
K861533	SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS	May 08, 1986	Substantially Equivalent	Sunfit, Inc.
K861107	TAN MATE HOME TANNING UNIT	Apr 25, 1986	Substantially Equivalent	Specialty Engineering, Inc.
K861076	RESIDENTIAL TANNING UNIT	Apr 14, 1986	Substantially Equivalent	Sunmaker, Inc.
K860932	ULTRASUN 1000 & 2000 SUNTANNING UNIT	Mar 28, 1986	Substantially Equivalent	Medical Device Consultants, Inc.
K860931	ULTRASUN 3000 AND 5000 SUNTANNING UNIT	Mar 28, 1986	Substantially Equivalent	Medical Device Consultants, Inc.
K860930	ULTRASUN 2500 SUNTANNING UNIT	Mar 28, 1986	Substantially Equivalent	Medical Device Consultants, Inc.
K860929	ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT	Mar 28, 1986	Substantially Equivalent	Medical Device Consultants, Inc.
K860859	UVA SUN SYSTEMS	Mar 28, 1986	Substantially Equivalent	Bremi
K860856	SILGMANN SOLARIUM SUN-MOBIL MODEL 0918	Mar 28, 1986	Substantially Equivalent	Solarium Tanning Hut
K860370	SAFE SUN 700 HOME TANNING UNIT	Mar 28, 1986	Substantially Equivalent	Safe Sun Corporation of America, Inc.
K860567	NORDIC SUN HOME TANNING UNIT	Mar 05, 1986	Substantially Equivalent	Nordic Sun Corporation of America
K860566	NORDIC SUN 24 LAMP TANNING BED	Mar 05, 1986	Substantially Equivalent	Nordic Sun Corporation of America
K860509	SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE	Mar 05, 1986	Substantially Equivalent	Ecomatic GmbH, Frankfurt, F.R.G.
K860489	EUROTAN BY AYK	Feb 24, 1986	Substantially Equivalent for Some Indications	Eurotan Intl.
K860198	MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING	Feb 18, 1986	Substantially Equivalent for Some Indications	Mottek Intl. Corp.
K854750	TOP SUN	Feb 14, 1986	Substantially Equivalent	Werner Schott Elektrogerate
K860347	SUNLAMP MODELS 24N, 30R, 30RE, 37RE	Feb 12, 1986	Substantially Equivalent	Gti, Inc.
K860144	SUM TAN VI	Feb 12, 1986	Substantially Equivalent	Nae, Inc.
K855162	ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR	Feb 12, 1986	Substantially Equivalent	Mottek Intl. Corp.
K860117	KRYPTOSOL (SUN LAMP)	Jan 30, 1986	Substantially Equivalent	Trademark Imports
K854932	ECUMOL ULTRAVIOLET FACE TANNING UNITS	Jan 30, 1986	Substantially Equivalent	Mottek Intl. Corp.
K854707	SUNTAINNING BOOTH	Jan 30, 1986	Substantially Equivalent for Some Indications	David Connell
K854594	PHOENIX U.V.A. SUNTAN BEDS	Jan 30, 1986	Substantially Equivalent for Some Indications	Phoenix U.V.A. , Ltd.
K854515	SHAW SUN SYSTEMS 1000, 2000 & 3200	Nov 25, 1985	Substantially Equivalent	Shaw Sun Systems
K854498	SPECTRA 724	Nov 25, 1985	Substantially Equivalent	Daavlin Co.
K854020	G-T 1000	Nov 15, 1985	Substantially Equivalent	G-T Products
K854224	GOLDEN RULE SUN TANNING BEDS	Nov 08, 1985	Substantially Equivalent	Golden Rule Tanning Co., Inc.
K854170	I.S.M. PRODUCT FAMILY MODEL R3600C	Nov 08, 1985	Substantially Equivalent	Intl. Solarium Manufacturer, Inc.
K854154	FOX BED MODEL 2001	Nov 08, 1985	Substantially Equivalent	Ace Mfg.
K854131	PHASE V-MODEL 1500 RUVA	Nov 08, 1985	Substantially Equivalent	Apollo'S Suntanning Supplies
K854111	EXPRESS TAN SUN CANOPY	Nov 08, 1985	Substantially Equivalent	Sunmaker Tanning Systems, Ltd.
K852534	ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9	Nov 08, 1985	Substantially Equivalent	R. A. Fischer Co. Corp.
K854171	I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC	Nov 06, 1985	Substantially Equivalent	Intl. Solarium Manufacturer, Inc.
K854004	FLUORESCENT T12 UVA TANNING LAMP	Oct 29, 1985	Substantially Equivalent	Light Sources, Inc.
K853846	SUN TANNING BED	Oct 29, 1985	Substantially Equivalent	Tan America Mfg.
K853833	TOP SUN MODELS 100,101,103 &139, 139-1, 139-3	Oct 24, 1985	Substantially Equivalent	Top Sun America, Inc.
K853911	UV-A SUNTANNING EQUIPMENT	Oct 21, 1985	Substantially Equivalent	Eurotan Intl.
K853752	SUN KING	Oct 21, 1985	Substantially Equivalent	American Chase Company, Inc.
K853692	SUN TANNING BED MODEL EC-3RF	Oct 01, 1985	Substantially Equivalent	Mottek Intl. Corp.
K853679	SUNJET MODELS 240/280	Oct 01, 1985	Substantially Equivalent	Sunjet Manufacturer, Inc.
K853587	UVATAN INDUS. UVATAN 900C, 900B/800 & 600C	Oct 01, 1985	Substantially Equivalent	Uvatan Industries , Ltd.
K853545	FLOURESCENT T12 UVA TANNING LAMP	Oct 01, 1985	Substantially Equivalent	Light Sources, Inc.
K853394	600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L	Sep 13, 1985	Substantially Equivalent	Interlab(Electromechanical)
K853248	CHALLENGER SUNRISE	Sep 13, 1985	Substantially Equivalent	Challenge Products, Inc.
K853177	ECUMOL ULTRAVIOLET SUNTANNNING BEDS	Aug 13, 1985	Substantially Equivalent	Mottek Intl. Corp.
K853046	TAN MODEL I	Aug 07, 1985	Substantially Equivalent	Philip Munsterman Tan, Inc.
K852957	SAHARA SUNBED	Jul 29, 1985	Substantially Equivalent	Sahara Sun Beds., Inc.
K852684	WALDMANN F85/100W UV21	Jul 11, 1985	Substantially Equivalent	Sylvania Lighting Products
K852576	WALDMANN F85/100W UV6	Jul 11, 1985	Substantially Equivalent	Sylvania Lighting Products
K851408	SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER	Jul 05, 1985	Substantially Equivalent	Applied Science, Inc.
K852579	THE SUNTANNING CO. TANNING BED	Jul 03, 1985	Substantially Equivalent	The Suntanning Company, Inc.
K852348	PHILIPS SOLARIUM HP 3134	Jun 27, 1985	Substantially Equivalent	Philips Int'L B.V.
K852243	KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS	Jun 27, 1985	Substantially Equivalent	Mottek Intl. Corp.
K852290	PRIVATAN HOME TANNING CENTER	Jun 21, 1985	Substantially Equivalent	Privatan, Inc.
K852149	PORTASUN MODEL 600/LI SUNLAMP	May 31, 1985	Substantially Equivalent	Portasun , Ltd.
K852053	ORIGINAL ULTRAVIOLET SUNTANNING LAMP	May 20, 1985	Substantially Equivalent	Mottek Intl. Corp.
K851859	FACIAL/UPPER BODY UNIT	May 14, 1985	Substantially Equivalent	Tannhut
K851858	FOLD AWAY HUT	May 14, 1985	Substantially Equivalent	Tannhut
K845029	SURGICAL POWER MAGNET	May 10, 1985	Substantially Equivalent	Friedman Labs, Inc.
K851532	SUNTANNING EQUIPMENT	May 07, 1985	Substantially Equivalent	Oakport Intl., Inc.
K851536	PHILIPS UV-A SOLARIUM TYPE HP 3141	May 01, 1985	Substantially Equivalent	Philips Int'L B.V.
K851535	PHILIPS UV-A SOLARIUM TYPE HP 3140	May 01, 1985	Substantially Equivalent	Philips Int'L B.V.
K851534	PHILIPS UV-A SOLARIUM TYPE HP 3150	May 01, 1985	Substantially Equivalent	Philips Int'L B.V.
K851533	PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP	May 01, 1985	Substantially Equivalent	Philips Int'L B.V.
K851255	SUN BEDS	Apr 18, 1985	Substantially Equivalent	Tannhut
K850660	SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY	Mar 01, 1985	Substantially Equivalent	Suntech USA, Inc.
K850493	SUNSHOWER MODEL HU-01-12L	Feb 28, 1985	Substantially Equivalent	Sunthetic Engineering, Inc.
K850206	PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP	Feb 21, 1985	Substantially Equivalent	Philips Int'L B.V.
K850205	PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP	Feb 21, 1985	Substantially Equivalent	Philips Int'L B.V.
K850204	PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP	Feb 21, 1985	Substantially Equivalent	Philips Int'L B.V.
K850203	PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP	Feb 21, 1985	Substantially Equivalent	Philips Int'L B.V.
K845001	MARTANIQUE 6-TUBE HOME SOLARIUM	Feb 21, 1985	Substantially Equivalent	Bainbridge Trading Co., Ltd.
K850042	SOLAR TAN - SOLARIA IV	Jan 14, 1985	Substantially Equivalent	Sola-Tan Intl.
K845028	MARTANIQUE 7-TUBE RUVA HOME SOLARIUM	Jan 14, 1985	Substantially Equivalent	Bainbridge Trading Co., Ltd.
K844870	SUNTAN CONNECTIONS BAHAMA SUN-BOOTH	Jan 09, 1985	Substantially Equivalent	Suntan Connection
K843902	SOLAR-GOLD UV-A BY EOS	Nov 08, 1984	Substantially Equivalent	Eos-Werke, Gunther GmbH
K844039	AZTECH INDUSTRIES SUNTANNING BED AZ100	Nov 05, 1984	Substantially Equivalent	Aztech Industries, Inc.
K843306	UVA SUNTANNING UNITS VARIOUS MODELS	Oct 31, 1984	Substantially Equivalent	Topsolo Sun Systems
K843814	EMUMOL ULTRAVIOLET SUNTANNING LAMP	Oct 25, 1984	Substantially Equivalent	Mottek Intl. Corp.
K843647	MTI 1200, 401 & 3500	Oct 25, 1984	Substantially Equivalent	Manufactured Tan Intl.
K842975	BROWNIE BOOTH BB1	Aug 17, 1984	Substantially Equivalent	Weingart, Inc.
K842787	SUNBED	Aug 15, 1984	Substantially Equivalent	Sun Health Systems
K842575	ULTRA-VIOLET A SOURCE LIGHT EMITTING	Aug 10, 1984	Substantially Equivalent	Sola-Tan Intl.
K842384	ULTRA-VIOLET EMITTING SUNLAMP PRODUCT	Aug 08, 1984	Substantially Equivalent	Sola-Tan Intl.
K841614	SUN BEDS	May 16, 1984	Substantially Equivalent	Sunworld Corp.
K840931	SUN BEDS	Apr 25, 1984	Substantially Equivalent	Wakewood Sunbeds
K840158	KOSMEDICO GMBH SUNLAMP PRODUCTS	Apr 24, 1984	Substantially Equivalent	Kosmedico, Kosmetische & Medizinisch
K840133	ULTRAVIOLET TANNING SYSTEMS	Apr 24, 1984	Substantially Equivalent	Merrittan Sunfun, Inc.
K840132	TANSEEKER	Apr 24, 1984	Substantially Equivalent	Senator Leisure Products, Ltd.
K840137	SILGMANN SOLARIUM S-TYPE 1218 COMBO	Apr 23, 1984	Substantially Equivalent	Tannhut
K834488	MERRITTAN SUN SYSTEM	Feb 09, 1984	Substantially Equivalent	Interfit A.G. Dba/Int'L Tanning Sys
K833524	SUNBED/SUNROOF TANNING DEVICE	Feb 09, 1984	Substantially Equivalent	J B Trading BV
K834495	UV-A SUNTANNING EQUIPMENT 1000-8000	Feb 06, 1984	Substantially Equivalent	Futuren, Inc.
K834493	EVERTAN SUNTAN BEDS	Feb 01, 1984	Substantially Equivalent	Oregon Beauty Supply
K834492	SALON -BODY TANNING BED	Jan 31, 1984	Substantially Equivalent	Grantan
K834491	UVA SUNTANNING LAMPS	Jan 27, 1984	Substantially Equivalent	D.P.R.M., Inc.
K833527	UV-A SUN TANNING EQUIPMENT	Jan 27, 1984	Substantially Equivalent	Tan America Mfg.
K833511	UV-A SUNTANNING EQUIPMENT-SILGMANN	Jan 27, 1984	Substantially Equivalent	Thomas G. Mason
K833490	SILGMANN SOLARIUMS-TYPE 1218 CANOPY &	Jan 27, 1984	Substantially Equivalent	Life Image, Inc.
K833350	KOSMEDICO GMBH SUN LAMP	Jan 27, 1984	Substantially Equivalent	Kosmedico, Kosmetische & Medizinisch
K833240	INT'L TANNING SYSTEMS B.V	Jan 27, 1984	Substantially Equivalent	Business Contacts USA
K832794	SUNTANNING BOOTHS AND BEDS	Jan 27, 1984	Substantially Equivalent	Tan-N-Trim
K827890	FOLDALITE UNIT	Aug 23, 1982	Substantially Equivalent	National Biological Corp.
K820492	SPECTRA305	Mar 31, 1982	Substantially Equivalent	Ultralite
K812225	METEC HELARIUM LOUNGE & SKY UNITS	Mar 15, 1982	Substantially Equivalent	Klafs Sunlight Corp.
K820123	SUNFLOWER	Mar 01, 1982	Substantially Equivalent	Solana, Inc.
K813307	UVA HEX UNIT	Dec 31, 1981	Substantially Equivalent	Sun Shanty, Inc.
K812663	SOLARIUM COMBINATION	Oct 29, 1981	Substantially Equivalent	Tech-Pro, Inc.
K812446	SUNLAMP	Oct 13, 1981	Substantially Equivalent	The Richmond Light Co.
K812579	SUNTANNING HOME UNIT	Oct 08, 1981	Substantially Equivalent	Tannhut
K812543	TANARAMA	Oct 08, 1981	Substantially Equivalent	Marketing Consultants of America
K812521	SUNTANNING DEVICE (SEPAR. FROM K812225)	Oct 02, 1981	Substantially Equivalent	Klafs Sunlight Corp.
K811870	UVA SUN TANNING EQUIPMENT	Aug 17, 1981	Substantially Equivalent	Cpc Systems, Inc.
K811586	F72T12/BL-S/SHO-O UVA SUNLAMP	Aug 13, 1981	Substantially Equivalent	Westinghouse Electric Corp.
K811585	F72T12/BL-S/HO UVA SUNLAMP	Aug 13, 1981	Substantially Equivalent	Westinghouse Electric Corp.
K810796	SUNTAN BOOTH	Aug 03, 1981	Substantially Equivalent	Gibson'S Mfg. Corp.
K811029	SUNLAMP	Jun 02, 1981	Substantially Equivalent	Williams & Connolly
K803264	SUNLAMP	Jun 02, 1981	Substantially Equivalent	Am Labs, Inc.
K810688	THE SUNFACTORY	Apr 23, 1981	Substantially Equivalent	Wesgold Marketing, Inc.
K810476	B.J.'S UVA SUN TAN BED W/SUN ROOF	Apr 23, 1981	Substantially Equivalent	B.J. Ent.
K801017	TANIT COMMERCIAL SUNTAN BOOTH	Jun 17, 1980	Substantially Equivalent	Tanit, Inc.
K800950	TANIT HOME SUNTANNING UNIT	Jun 04, 1980	Substantially Equivalent	Tanit, Inc.
K800160	SUN-TANNING BOOTHS	Mar 03, 1980	Substantially Equivalent	World Wide Sun Systems, Inc.
K792500	UVB LIGHT BOX - UVB LIGHT BOOTH	Feb 19, 1980	Substantially Equivalent	Sun Shanty, Inc.
K790167	SUNLAMP	Mar 21, 1979	Substantially Equivalent	Kneilsly Group Ent.
K770862	BLACK LAMPS,F72T12/BL/HO	Jun 27, 1977	Substantially Equivalent	Dermatron Corp.
K761179	PSORALITE	May 03, 1977	Substantially Equivalent	Ultralite
K761189	HOUVA-LITE SOLE UNIT #502	Feb 28, 1977	Substantially Equivalent	National Biological Corp.
K761188	HOUVA-LITE PALM UNIT #501	Feb 28, 1977	Substantially Equivalent	National Biological Corp.
K761187	HOUVA-LITE LEG UNIT #701	Feb 28, 1977	Substantially Equivalent	National Biological Corp.
K761186	HOUVA-LITE ARM UNIT #601	Feb 28, 1977	Substantially Equivalent	National Biological Corp.
K760482	SUNLAMP (F40-UVB & F20-UVB)	Sep 15, 1976	Substantially Equivalent	Dermatron Corp.
K760471	LAMP, FLOURESCENT BLACK, HIGH OUTPUT	Sep 15, 1976	Substantially Equivalent	Dermatron Corp.