Light, Ultraviolet, Dermatological
FDA product code FTC · 267 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4630
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-09-15 – 2026-05-01
FTC
2026-05-01
FTC
2026-03-04
Klär Lite (RCW-KL1000)
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FTC
2025-04-07
Ultraviolet Phototherapy Device
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FTC
2025-03-13
308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
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FTC
2025-02-06
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
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FTC
2024-12-19
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
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FTC
2023-12-13
DT Controlled Phototherapy Equipment
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FTC
2023-03-27
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
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FTC
2023-03-24
3 Series NeoLux
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FTC
2023-03-08
Enhanced AURORA™ Medical Diode System, and related accessories
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FTC
2022-04-22
1 Series Phototherapy Equipment
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FTC
2021-12-10
i8 Tanning Booth
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FTC
2021-11-04
7 Series Phototherapy Device
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FTC
2021-06-22
M Series Phototherapy Equipment
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FTC
2020-12-15
308nm Excimer UV-light Skin Therapy System
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FTC
2020-12-15
308nm Excimer System
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FTC
2020-07-02
Psoria-Shield AURORA
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FTC
2020-05-13
308nm Excimer System
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FTC
2020-02-06
UV Radiation Treatment System
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FTC
2019-12-11
Exciplex
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FTC
2019-01-11
UV Phototherapy
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FTC
2018-10-29
ClearLink Controlled Phototherapy Equipment
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FTC
2018-07-30
308nm Excimer System
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FTC
2018-01-30
Luma Light System
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FTC
2017-10-13
Exciplex308nm
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FTC
2017-05-23
Skylit Phototherapy System
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FTC
2016-06-30
3 Series Phototherapy Unit
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FTC
2013-12-24
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
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FTC
2012-05-25
MOBILE VERSA LIGHT
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FTC
2011-10-20
SMART TOUCH UVTHERAPY MULTIPLE MACHINE
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FTC
2011-08-29
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
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FTC
2011-04-27
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
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FTC
2011-02-22
ML24000 UVA-1 PHOTOTHERAPY UNIT
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FTC
2011-02-10
PSORIA-LIGHT
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FTC
2010-04-28
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
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FTC
2009-11-05
LH-75 PHOTOTHERAPY SYSTEM
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FTC
2009-02-26
LH-75T PHOTOTHERAPY SYSTEM
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FTC
2008-12-17
ML24000 UVA-1 PHOTOTHERAPY CABINET
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FTC
2008-01-23
VERSA LITE
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FTC
2008-01-18
DERMAPAL WITH DIGITAL TIMER
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FTC
2007-12-26
308 DERMATOLOGICAL EXCIMER SYSTEM
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FTC
2007-10-16
RESOLVE UVB PHOTOTHERAPY SYSTEM
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FTC
2007-05-22
PANOSOL II TRU-BLU, MODEL UBL-417
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FTC
2007-01-17
3 SERIES PHOTOTHERAPY CABINET
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FTC
2006-08-04
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
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FTC
2006-05-25
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
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FTC
2005-11-18
UVBIOTEK MODELS 3200B AND 4000B
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FTC
2005-10-17
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO
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FTC
2005-05-05
CYNOSUREA ECLILITE AND ECLILITE U
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FTC
2005-04-19
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
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FTC
2004-10-14
3 SERIES PHOTOTHERAPY CABINET
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FTC
2004-06-09
HOUVA 3 PHOTOTHERAPY SYSTEM
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FTC
2004-04-05
LOVELY SYSTEM
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FTC
2004-02-13
LEVIA PHOTOTHERAPY SYSTEM
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FTC
2003-09-10
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
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FTC
2003-01-17
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
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FTC
2002-09-10
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
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FTC
2002-08-23
BCLEAR
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FTC
2002-07-18
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
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FTC
2002-05-16
PHILIPS PLS9W/12/2P UVB
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FTC
2002-05-16
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
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FTC
2002-05-16
BCLEAR
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FTC
2001-12-14
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
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FTC
1998-10-28
HANDISOL WOUND HEALING
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FTC
1995-05-19
PHOTOTHERAPEUTIX MODEL 2480AB
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FTC
1995-02-21
PHOTOTHERAPEUTIX MODEL 2400B
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FTC
1995-02-21
PHOTOTHERAPEUTIX MODEL 1650B
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FTC
1995-02-21
PHOTOTHERAPEUTIX MODEL 800B
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FTC
1995-02-17
PHOTOTHERAPEUTIX MODEL 1600B
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FTC
1995-02-17
PHOTOTHERAPEUTIX MODEL 3200A
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FTC
1994-03-07
SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT
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FTC
1994-02-24
TL 20W/12/RS & TL 40W/12/RS
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FTC
1993-12-16
UVISOL AND UVISOL II
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FTC
1993-09-23
ESB 2400 SEI
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FTC
1993-08-26
PSORALITE
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FTC
1993-02-23
PHOTOTHERAPY TIMER
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FTC
1992-12-29
FREE SUN PRO DESIGN 3000 AND 3800
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FTC
1992-11-20
HANDISOL
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FTC
1992-09-02
TL100W/12
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FTC
1992-03-04
MEDICAL SUNLAMP FOR PHOTOTHERAPY
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FTC
1991-10-28
PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
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FTC
1991-05-23
TL100W/01 UVB LAMP
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FTC
1990-12-24
PANOSOL II UAB-228
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FTC
1990-12-24
PANOSOL II UVB-206
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FTC
1990-12-24
PANOSOL II UVA-218
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FTC
1990-11-21
MODEL 6/01 UV-B FIXTURE
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FTC
1990-04-26
U.V. SUNLAMP 95UF-II
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FTC
1990-03-28
FLUORESCENT T12 UVA LAMP
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FTC
1990-03-27
U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
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FTC
1989-12-27
ALISUN SUNTANNING BED
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FTC
1989-12-27
SUNTANNING BED, INC. T12 UVA TANNING LAMPS
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FTC
1989-11-27
REMINGTON TANFASTIC HANDHELD TANNING WAND
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FTC
1989-06-02
HOUVA II UVA/UVB
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FTC
1989-06-02
HOUVA II UVB
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FTC
1989-05-11
PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
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FTC
1989-01-09
SHAW SUN SYSTEMS MODEL 2400
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FTC
1989-01-09
HOUVA II UVA
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FTC
1988-10-03
TANNING BED
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FTC
1988-09-28
U. V. SUNLAMP 95UF-11
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FTC
1988-08-30
HOUVA-BED
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