Light, Ultraviolet, Dermatological
FDA product code FTC · Class II (moderate risk) · 21 CFR 878.4630 · General, Plastic Surgery
272510(k) clearances
0PMA approvals
10recalls
Manufacturers
- National Biological Corp. 27
- Daavlin Distributing Co. 17
- Philips Int'L B.V. 9
- Mottek Intl. Corp. 8
- Light Sources, Inc. 8
- Philips Lighting Co. 6
- Avex Industries , Ltd. 6
- Psoralite Corp. 5
- Tannhut 5
- Medical Device Consultants, Inc. 4
- Xuzhou Kernel Medical Equipment Co., Ltd. 4
- Solarc Systems, Inc. 4
- Lumenis, Inc. 3
- Daavlin Co. 3
- Lerner Medical Devices, Inc. 3
- Theralight, Inc. 3
- Klafs Sunlight Corp. 3
- Sola-Tan Intl. 3
- Ultralite 3
- Dermatron Corp. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO)FTC · Traditional | Choyang Medics Co., Ltd. | 05/01/2026SE |
| K253871 | Klär Lite (RCW-KL1000)FTC · Traditional | Radcliffe Watts, LLC | 03/04/2026SE |
| K250425 | Ultraviolet Phototherapy DeviceFTC · Traditional | APK Technology Co., Ltd. | 04/07/2025SE |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…FTC · Traditional | Boston Aesthetics, Inc. | 03/13/2025SE |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 02/06/2025SE |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD…FTC · Traditional | Shanghai Sigma High-Tech Co., Ltd. | 12/19/2024SE |
| K233811 | DT Controlled Phototherapy EquipmentFTC · Special | Daavlin Distributing Co. | 12/13/2023SE |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)FTC · Traditional | Shenzhen Honpal Optoelectronic Technology Co.… | 03/27/2023SE |
| K230382 | 3 Series NeoLuxFTC · Special | Daavlin Distributing Co. | 03/24/2023SE |
| K230076 | Enhanced AURORA Medical Diode System, and related accessoriesFTC · Traditional | Psoria-Shield, Inc. | 03/08/2023SE |
| K220840 | 1 Series Phototherapy EquipmentFTC · Special | Daavlin Distributing Co. | 04/22/2022SE |
| K210004 | i8 Tanning BoothFTC · Traditional | Ultrasun International B.V. | 12/10/2021SE |
| K212510 | 7 Series Phototherapy DeviceFTC · Traditional | Daavlin Distributing Co. | 11/04/2021SE |
| K210881 | M Series Phototherapy EquipmentFTC · Traditional | Daavlin Distributing Co. | 06/22/2021SE |
| K202827 | 308nm Excimer UV-light Skin Therapy SystemFTC · Traditional | Shenzhen Gsd Tech Co., Ltd. | 12/15/2020SE |
| K200971 | 308nm Excimer SystemFTC · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 12/15/2020SE |
| K192411 | Psoria-Shield AURORAFTC · Special | Psoria-Shield | 07/02/2020SE |
| K192642 | 308nm Excimer SystemFTC · Traditional | Chongqing Peninsula Medical Technology Co., Ltd. | 05/13/2020SE |
| K191571 | UV Radiation Treatment SystemFTC · Traditional | Xuzhou Yongkang Electronic Science Technology… | 02/06/2020SE |
| K191086 | ExciplexFTC · Traditional | Clarteis | 12/11/2019SE |
| K181805 | UV PhototherapyFTC · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 01/11/2019SE |
| K182215 | ClearLink Controlled Phototherapy EquipmentFTC · Traditional | Daavlin Distributing Company | 10/29/2018SE |
| K172273 | 308nm Excimer SystemFTC · Traditional | Chongqing Peninsula Medical Technology Co., Ltd. | 07/30/2018SE |
| K173436 | Luma Light SystemFTC · Traditional | Luma Therapeutics | 01/30/2018SE |
| K171702 | Exciplex308nmFTC · Traditional | Clarteis | 10/13/2017SE |
| K170489 | Skylit Phototherapy SystemFTC · Traditional | Skylit Medical | 05/23/2017SE |
| K153749 | 3 Series Phototherapy UnitFTC · Special | Daavlin Distributing Company | 06/30/2016SE |
| K151795 | ML24000 UVA-1 Phototherapy CabinetFTC · Special | Daavlin Distributing Co. | 09/10/2015SE |
| K150752 | GME ExSys 308FTC · Traditional | Gme (German Medical Engineering) GmbH | 07/31/2015SE |
| K150912 | Houva-NET Control SystemFTC · Traditional | National Biological Corporation | 07/10/2015SE |
| K134009 | UV Biotek Single Panel, UV Biotek Multi-DirectionalFTC · Traditional | Medtek Lighting | 10/15/2014SE |
| K132643 | UV PhototherapyFTC · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 01/30/2014SE |
| K130519 | Philips Uva (/09) and Philips UVA-1 (/10) Ultraviolet LampsFTC · Traditional | Philips Lighting Company | 12/24/2013SE |
| K111049 | Mobile Versa LightFTC · Traditional | Medtek Lighting Corp | 05/25/2012SE |
| K110912 | Smart Touch Uvtherapy Multiple MachineFTC · Traditional | Daavlin Distributing Co. | 10/20/2011SE |
| K111172 | 4 Series Phototherapy Unit Model 4 SeriesFTC · Traditional | Daavlin Distributing Co. | 08/29/2011SE |
| K103204 | Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit FamilyFTC · Traditional | Solarc Systems, Inc. | 04/27/2011SE |
| K103708 | ML24000 UVA-1 Phototherapy UnitFTC · Traditional | The Daavlin Distributing Company | 02/22/2011SE |
| K103540 | Psoria-LightFTC · Traditional | Psoria-Shield, Inc. | 02/10/2011SE |
| K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4FTC · Traditional | Daavlin Distributing Co. | 04/28/2010SE |
| K091568 | LH-75 Phototherapy SystemFTC · Traditional | Lerner Medical Devices, Inc. | 11/05/2009SE |
| K090097 | LH-75T Phototherapy SystemFTC · Traditional | Lerner Medical Devices, Inc. | 02/26/2009SE |
| K082731 | ML24000 UVA-1 Phototherapy CabinetFTC · Traditional | Daavlin Distributing Co. | 12/17/2008SE |
| K073503 | Versa LiteFTC · Traditional | Diomedics, Inc. | 01/23/2008SE |
| K073587 | Dermapal with Digital TimerFTC · Traditional | Daavlin Distributing Co. | 01/18/2008SE |
| K073066 | 308 Dermatological Excimer SystemFTC · Traditional | Quantel Medical, Inc. | 12/26/2007SE |
| K072035 | Resolve Uvb Phototherapy SystemFTC · Traditional | Allux Medical | 10/16/2007SE |
| K070934 | Panosol II Tru-Blu, Model UBL-417FTC · Traditional | National Biological Corp. | 05/22/2007SE |
| K063621 | 3 Series Phototherapy CabinetFTC · Traditional | Daavlin Co. | 01/17/2007SE |
| K061589 | Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit FamilyFTC · Traditional | Solarc Systems, Inc. | 08/04/2006SE |
| K061295 | Versaclear Skin Therapy System, Model 100FTC · Special | Theralight, Inc. | 05/25/2006SE |
| K051330 | Uvbiotek Models 3200B and 4000BFTC · Traditional | Medtek Lighting Corporation | 11/18/2005SE |
| K052660 | Model 672-BD, Home Uvb Light Source (Jordan Light); Model 2400, 4 (6 Foot) Ho UV Light…FTC · Traditional | The Richmond Light Co. | 10/17/2005SE |
| K050080 | Cynosurea Eclilite and Eclilite UFTC · Traditional | Cynosure, Inc. | 05/05/2005SE |
| K050695 | Flex Controlled Phototherapy EquipmentFTC · Traditional | Daavlin Distributing Co. | 04/19/2005SE |
| K042502 | 3 Series Phototherapy CabinetFTC · Traditional | Daavlin Distributing Co. | 10/14/2004SE |
| K041212 | Houva 3 Phototherapy SystemFTC · Special | National Biological Corp. | 06/09/2004SE |
| K033946 | Lovely SystemFTC · Traditional | Msq (M2) , Ltd. | 04/05/2004SE |
| K040062 | Levia Phototherapy SystemFTC · Traditional | Lerner Medical Devices, Inc. | 02/13/2004SE |
| K031800 | Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device…FTC · Traditional | Solarc Systems, Inc. | 09/10/2003SE |
| K024020 | Theralight UV120-2 Uva/Uvb Phototherapy SystemFTC · Traditional | Theralight, Inc. | 01/17/2003SE |
| K022104 | Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,UVB Narrow Band…FTC · Traditional | Daavlin Distributing Co. | 09/10/2002SE |
| K021762 | BclearFTC · Traditional | Lumenis, Inc. | 08/23/2002SE |
| K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2FTC · Traditional | Theralight, Inc. | 07/18/2002SE |
| K021514 | Philips PLS9W/12/2P UvbFTC · Traditional | Philips Lighting Co. | 05/16/2002SE |
| K021092 | Philips TL 20W/01RS Uv-B, Philips Pl-S 9W/01/2P UV, and Philips Pl-L 36W/01/4P Uv-BFTC · Traditional | Philips Lighting Co. | 05/16/2002SE |
| K020591 | BclearFTC · Traditional | Lumenis | 05/16/2002SE |
| K011197 | Dermaclear Uv-B Phototherapy SystemFTC · Traditional | Lumenis | 12/14/2001SE |
| K982082 | Handisol Wound HealingFTC · Traditional | National Biological Corp. | 10/28/1998SE |
| K935525 | Phototherapeutix Model 2480ABFTC · Traditional | Avex Industries , Ltd. | 05/19/1995SE |
| K933954 | Phototherapeutix Model 2400BFTC · Traditional | Avex Industries , Ltd. | 02/21/1995SE |
| K933953 | Phototherapeutix Model 1650BFTC · Traditional | Avex Industries , Ltd. | 02/21/1995SE |
| K933952 | Phototherapeutix Model 800BFTC · Traditional | Avex Industries , Ltd. | 02/21/1995SE |
| K935526 | Phototherapeutix Model 1600BFTC · Traditional | Avex Industries , Ltd. | 02/17/1995SE |
| K935524 | Phototherapeutix Model 3200AFTC · Traditional | Avex Industries , Ltd. | 02/17/1995SE |
| K935572 | Solarc 1000 Series Ultraviolet Phototherapy Lamp UnitFTC · Traditional | Solarc Systems, Inc. | 03/07/1994SE |
| K935840 | TL 20W/12/RS & TL 40W/12/RSFTC · Traditional | Philips Lighting Co. | 02/24/1994SE |
| K934808 | Uvisol and Uvisol IIFTC · Traditional | National Biological Corp. | 12/16/1993SE |
| K933146 | Esb 2400 SeiFTC · Traditional | Esb, Inc., Div. of Ray-O-Vac | 09/23/1993SE |
| K930856 | PsoraliteFTC · Traditional | Daavlin Co. | 08/26/1993SE |
| K924969 | Phototherapy TimerFTC · Traditional | National Biological Corp. | 02/23/1993SE |
| K925171 | Free Sun Pro Design 3000 and 3800FTC · Traditional | Free Sun Prod. AB | 12/29/1992SE |
| K924077 | HandisolFTC · Traditional | National Biological Corp. | 11/20/1992SE |
| K922963 | TL100W/12FTC · Traditional | Philips Lighting Co. | 09/02/1992SE |
| K915426 | Medical Sunlamp for PhototherapyFTC · Traditional | American Sunlight, Inc. | 03/04/1992SE |
| K913760 | Psoralite , Phototherapy Treatment EquipmentFTC · Traditional | Psoralite Corp. | 10/28/1991SE |
| K910767 | TL100W/01 Uvb LampFTC · Traditional | Philips Lighting Co. | 05/23/1991SE |
| K904428 | Panosol II UAB-228FTC · Traditional | National Biological Corp. | 12/24/1990SE |
| K904427 | Panosol II UVB-206FTC · Traditional | National Biological Corp. | 12/24/1990SE |
| K904426 | Panosol II UVA-218FTC · Traditional | National Biological Corp. | 12/24/1990SE |
| K904425 | Model 6/01 Uv-B FixtureFTC · Traditional | Strato-Ray Co. | 11/21/1990SE |
| K901324 | U.V. Sunlamp 95UF-IIFTC · Traditional | Light Sources, Inc. | 04/26/1990SE |
| K900649 | Fluorescent T12 Uva LampFTC · Traditional | Light Sources, Inc. | 03/28/1990SE |
| K900693 | U.V. Sunlamp (U.V. Light, Dermatologic)FTC · Traditional | Light Sources, Inc. | 03/27/1990SE |
| K896831 | Alisun Suntanning BedFTC · Traditional | Alisun America, Ltd. | 12/27/1989SE |
| K896191 | Suntanning Bed, Inc. T12 Uva Tanning LampsFTC · Traditional | Sunbronze | 12/27/1989SE |
| K895410 | Remington Tanfastic Handheld Tanning WandFTC · Traditional | Remington Products Company, LLC | 11/27/1989SE |
| K885029 | Houva II Uva/UvbFTC · Traditional | National Biological Corp. | 06/02/1989SE |
| K885026 | Houva II UvbFTC · Traditional | National Biological Corp. | 06/02/1989SE |
| K890084 | Psoralite Phototherapy Treatment Booth, MDL 45000FTC · Traditional | Psoralite Corp. | 05/11/1989SESD |
| K885184 | Shaw Sun Systems Model 2400FTC · Traditional | Shaw Sun Systems | 01/09/1989SE |
| K885025 | Houva II UvaFTC · Traditional | National Biological Corp. | 01/09/1989SE |
| K883929 | Tanning BedFTC · Traditional | Dallas Tan, Inc. | 10/03/1988SE |
| K883952 | U. V. Sunlamp 95UF-11FTC · Traditional | Light Sources, Inc. | 09/28/1988SE |
| K882722 | Houva-BedFTC · Traditional | National Biological Corp. | 08/30/1988SE |
| K881923 | Ultraviolet Resources Int'L Model 2-FS72FTC · Traditional | Ultraviolet Resources Intl. | 07/07/1988SE |
| K881385 | Psoralite Phototherapy Treatment Booth/PanelFTC · Traditional | Psoralite Corp. | 04/13/1988SE |
| K874889 | U.V. Sunlamp 95 UF-11FTC · Traditional | Light Sources, Inc. | 12/30/1987SE |
| K873430 | Fac GE1/HI Perf Fac Upr Body TE2/FULL Body Ga 8-12FTC · Traditional | Klafs Sunlight Corp. | 09/25/1987SE |
| K872648 | Solar Gold Uva Sun Tanning BedFTC · Traditional | An-Mar International, Ltd. | 08/04/1987SE |
| K872707 | Panosol 2000 624-404FTC · Traditional | National Biological Corp. | 07/27/1987SE |
| K872706 | Panosol 2000 624-616FTC · Traditional | National Biological Corp. | 07/27/1987SE |
| K872651 | Panosol 2000 624-414FTC · Traditional | National Biological Corp. | 07/27/1987SE |
| K872650 | Panosol 2000 624-604FTC · Traditional | National Biological Corp. | 07/27/1987SE |
| K872649 | Hand/Foot Uva/Uvb 624-224FTC · Traditional | National Biological Corp. | 07/27/1987SE |
| K872605 | Hand/Foot Uva 624-218FTC · Traditional | National Biological Corp. | 07/24/1987SE |
| K872604 | Hand/Foot 624-208FTC · Traditional | National Biological Corp. | 07/24/1987SE |
| K871237 | Sun Capsule I & II Suntanning BoothFTC · Traditional | Sun Capsule, Inc. | 04/23/1987SE |
| K870167 | U.V. Sunlamp 95UF-11FTC · Traditional | Light Sources, Inc. | 02/09/1987SE |
| K864511 | Psoralite 18400 SeriesFTC · Traditional | Psoralite Corp. | 02/04/1987SE |
| K864510 | Psoralite 12800 SeriesFTC · Traditional | Psoralite Corp. | 02/04/1987SE |
| K864546 | Maxi-Tan DeviceFTC · Traditional | National Biological Corp. | 01/09/1987SE |
| K864907 | Suntanning LampFTC · Traditional | Interlectric Corp. | 01/05/1987SE |
| K864485 | Sunfit SunlampFTC · Traditional | Sunfit, Inc. | 12/17/1986SE |
| K863937 | Osram Ultramed 400 WFTC · Traditional | Osram GmbH | 11/04/1986SN |
| K863555 | Bremi Beauty BronzeFTC · Traditional | Handelsonderneming Bremi B.V. | 10/02/1986SE |
| K863518 | Weingart Model 1000 Sunlamp ProductFTC · Traditional | Weingart, Inc. | 10/02/1986SE |
| K862608 | Spertilite Phototherapy LampFTC · Traditional | Cooper-Hewitt Electric Co. | 08/06/1986SN |
| K862372 | Ultratan Tanning SystemFTC · Traditional | Health Systems Intl., Inc. | 07/09/1986SE |
| K862341 | Tanning SofaFTC · Traditional | Hardwood Design Shop | 07/09/1986SE |
| K861963 | Ultralite HF1236 Hand and Foot SystemFTC · Traditional | Ultralite | 06/25/1986SE |
| K862263 | Persunal Tan, Model No. HU-0208LFTC · Traditional | Sunthetic Engineering, Inc. | 06/20/1986SE |
| K862142 | Sun-Dreamer Suntanning BedFTC · Traditional | Sun-Dream Tanning , Ltd. | 06/17/1986SE |
| K862097 | Face TannerFTC · Traditional | Tan America Mfg. | 06/17/1986SE |
| K861989 | Modification of Suntana Sun System BedFTC · Traditional | Hawaiian Tan Spa | 06/09/1986SE |
| K861705 | Corona 3000 (Dermatologic Ultraviolet Lamp)FTC · Traditional | Vita-Tan Corp. | 05/16/1986SE |
| K861636 | Miami-SunnyFTC · Traditional | Sunworld Corp. | 05/16/1986SE |
| K861570 | Alpha Tan 1000 and Alpha Tan 1200FTC · Traditional | Midwest Marketing Service | 05/13/1986SE |
| K861447 | Alisun -Type 1200, Type 1000/800 and Type 700/900FTC · Traditional | Southern Exposure, Inc. | 05/13/1986SE |
| K861533 | Sunfit, Ultra Violet Lamps and Sunlamp ProductsFTC · Traditional | Sunfit, Inc. | 05/08/1986SE |
| K861107 | Tan Mate Home Tanning UnitFTC · Traditional | Specialty Engineering, Inc. | 04/25/1986SE |
| K861076 | Residential Tanning UnitFTC · Traditional | Sunmaker, Inc. | 04/14/1986SE |
| K860932 | Ultrasun 1000 & 2000 Suntanning UnitFTC · Traditional | Medical Device Consultants, Inc. | 03/28/1986SE |
| K860931 | Ultrasun 3000 and 5000 Suntanning UnitFTC · Traditional | Medical Device Consultants, Inc. | 03/28/1986SE |
| K860930 | Ultrasun 2500 Suntanning UnitFTC · Traditional | Medical Device Consultants, Inc. | 03/28/1986SE |
| K860929 | Ultrasun 4000 FT & 15000-8 Suntanning UnitFTC · Traditional | Medical Device Consultants, Inc. | 03/28/1986SE |
| K860859 | Uva Sun SystemsFTC · Traditional | Bremi | 03/28/1986SE |
| K860856 | Silgmann Solarium Sun-Mobil Model 0918FTC · Traditional | Solarium Tanning Hut | 03/28/1986SE |
| K860370 | Safe Sun 700 Home Tanning UnitFTC · Traditional | Safe Sun Corporation of America, Inc. | 03/28/1986SE |
| K860567 | Nordic Sun Home Tanning UnitFTC · Traditional | Nordic Sun Corporation of America | 03/05/1986SE |
| K860566 | Nordic Sun 24 Lamp Tanning BedFTC · Traditional | Nordic Sun Corporation of America | 03/05/1986SE |
| K860509 | Sunbed/Canopy, Models Gti 24N,30R,30RE & 37REFTC · Traditional | Ecomatic GmbH, Frankfurt, F.R.G. | 03/05/1986SE |
| K860489 | Eurotan by AykFTC · Traditional | Eurotan Intl. | 02/24/1986SN |
| K860198 | Model 7500/000 Kettler Holiday Solar Sun TanningFTC · Traditional | Mottek Intl. Corp. | 02/18/1986SN |
| K854750 | Top SunFTC · Traditional | Werner Schott Elektrogerate | 02/14/1986SE |
| K860347 | Sunlamp Models 24N, 30R, 30RE, 37REFTC · Traditional | Gti, Inc. | 02/12/1986SE |
| K860144 | Sum Tan ViFTC · Traditional | Nae, Inc. | 02/12/1986SE |
| K855162 | Ultraviolet Sun Tanning Unit Kettler Holiday SolarFTC · Traditional | Mottek Intl. Corp. | 02/12/1986SE |
| K860117 | Kryptosol (Sun Lamp)FTC · Traditional | Trademark Imports | 01/30/1986SE |
| K854932 | Ecumol Ultraviolet Face Tanning UnitsFTC · Traditional | Mottek Intl. Corp. | 01/30/1986SE |
| K854707 | Suntainning BoothFTC · Traditional | David Connell | 01/30/1986SN |
| K854594 | Phoenix U.V.A. Suntan BedsFTC · Traditional | Phoenix U.V.A. , Ltd. | 01/30/1986SN |
| K854515 | Shaw Sun Systems 1000, 2000 & 3200FTC · Traditional | Shaw Sun Systems | 11/25/1985SE |
| K854498 | Spectra 724FTC · Traditional | Daavlin Co. | 11/25/1985SE |
| K854020 | G-T 1000FTC · Traditional | G-T Products | 11/15/1985SE |
| K854224 | Golden Rule Sun Tanning BedsFTC · Traditional | Golden Rule Tanning Co., Inc. | 11/08/1985SE |
| K854170 | I.S.M. Product Family Model R3600CFTC · Traditional | Intl. Solarium Manufacturer, Inc. | 11/08/1985SE |
| K854154 | Fox Bed Model 2001FTC · Traditional | Ace Mfg. | 11/08/1985SE |
| K854131 | Phase V-Model 1500 RuvaFTC · Traditional | Apollo'S Suntanning Supplies | 11/08/1985SE |
| K854111 | Express Tan Sun CanopyFTC · Traditional | Sunmaker Tanning Systems, Ltd. | 11/08/1985SE |
| K852534 | Ultraviolet Treatment Lamps UV-8 & UV-9FTC · Traditional | R. A. Fischer Co. Corp. | 11/08/1985SE |
| K854171 | I.S.M. Product Family Model P2400C,A & AbcFTC · Traditional | Intl. Solarium Manufacturer, Inc. | 11/06/1985SE |
| K854004 | Fluorescent T12 Uva Tanning LampFTC · Traditional | Light Sources, Inc. | 10/29/1985SE |
| K853846 | Sun Tanning BedFTC · Traditional | Tan America Mfg. | 10/29/1985SE |
| K853833 | Top Sun Models 100,101,103 &139, 139-1, 139-3FTC · Traditional | Top Sun America, Inc. | 10/24/1985SE |
| K853911 | Uv-A Suntanning EquipmentFTC · Traditional | Eurotan Intl. | 10/21/1985SE |
| K853752 | Sun KingFTC · Traditional | American Chase Company, Inc. | 10/21/1985SE |
| K853692 | Sun Tanning Bed Model EC-3RFFTC · Traditional | Mottek Intl. Corp. | 10/01/1985SE |
| K853679 | Sunjet Models 240/280FTC · Traditional | Sunjet Manufacturer, Inc. | 10/01/1985SE |
| K853587 | Uvatan Indus. Uvatan 900C, 900B/800 & 600CFTC · Traditional | Uvatan Industries , Ltd. | 10/01/1985SE |
| K853545 | Flourescent T12 Uva Tanning LampFTC · Traditional | Light Sources, Inc. | 10/01/1985SE |
| K853394 | 600/L 5X6' Uva 85W Lamps, 5X5 Uva 65W Lamps 500/LFTC · Traditional | Interlab(Electromechanical) | 09/13/1985SE |
| K853248 | Challenger SunriseFTC · Traditional | Challenge Products, Inc. | 09/13/1985SE |
| K853177 | Ecumol Ultraviolet Suntannning BedsFTC · Traditional | Mottek Intl. Corp. | 08/13/1985SE |
| K853046 | Tan Model IFTC · Traditional | Philip Munsterman Tan, Inc. | 08/07/1985SE |
| K852957 | Sahara SunbedFTC · Traditional | Sahara Sun Beds., Inc. | 07/29/1985SE |
| K852684 | Waldmann F85/100W UV21FTC · Traditional | Sylvania Lighting Products | 07/11/1985SE |
| K852576 | Waldmann F85/100W UV6FTC · Traditional | Sylvania Lighting Products | 07/11/1985SE |
| K851408 | Sun Flower Solette Minette Nova Super 28X, Pro SerFTC · Traditional | Applied Science, Inc. | 07/05/1985SE |
| K852579 | The Suntanning Co. Tanning BedFTC · Traditional | The Suntanning Company, Inc. | 07/03/1985SE |
| K852348 | Philips Solarium HP 3134FTC · Traditional | Philips Int'L B.V. | 06/27/1985SE |
| K852243 | Kettler Ultraviolet Suntanning Benches & LiftsFTC · Traditional | Mottek Intl. Corp. | 06/27/1985SE |
| K852290 | Privatan Home Tanning CenterFTC · Traditional | Privatan, Inc. | 06/21/1985SE |
| K852149 | Portasun Model 600/LI SunlampFTC · Traditional | Portasun , Ltd. | 05/31/1985SE |
| K852053 | Original Ultraviolet Suntanning LampFTC · Traditional | Mottek Intl. Corp. | 05/20/1985SE |
| K851859 | Facial/Upper Body UnitFTC · Traditional | Tannhut | 05/14/1985SE |
| K851858 | Fold Away HutFTC · Traditional | Tannhut | 05/14/1985SE |
| K845029 | Surgical Power MagnetFTC · Traditional | Friedman Labs, Inc. | 05/10/1985SE |
| K851532 | Suntanning EquipmentFTC · Traditional | Oakport Intl., Inc. | 05/07/1985SE |
| K851536 | Philips Uv-A Solarium Type HP 3141FTC · Traditional | Philips Int'L B.V. | 05/01/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2744-2026 Class II | Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed… | Daavlin Distributing Company | 03/05/2026Open, Classified |
| Z-2743-2026 Class II | Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed… | Daavlin Distributing Company | 03/05/2026Open, Classified |
| Z-2742-2026 Class II | Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed… | Daavlin Distributing Company | 03/05/2026Open, Classified |
| Z-2295-2026 Class II | Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders…Some of the Calibration/Output Certificates had the outputs reversed. | Daavlin Distributing Company | 12/10/2025Open, Classified |
| Z-1074-2022 Class II | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software…Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment… | Daavlin Distributing Company | 04/26/2022Open, Classified |
| Z-1073-2022 Class II | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software…Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment… | Daavlin Distributing Company | 04/26/2022Open, Classified |
| Z-1683-2017 Class II | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a…The wiring may allow the lamps to turn on with the key switch rather than the timer. | National Biological Corp | 01/27/2017Terminated |
| Z-1778-2013 Class III | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a…The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual… | National Biological Corp | 04/09/2013Terminated |
| Z-1779-2013 Class III | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a…The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual… | National Biological Corp | 04/08/2013Terminated |
| Z-1309-2008 | HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10…Software allows operator to override "low line voltage" error warning and store light intensity value. | National Biological Corp | 02/19/2008Terminated |