Atlas FDA

FTC

272 FDA 510(k) clearances · Product code

43 daysmedian time to decision
160 days90th percentile
272clearances measured

FDA profile

Official device name
Light, Ultraviolet, Dermatological
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4630
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 2 · 2001: 1 · 2002: 2 · 2015: 8 · 2019: 14 · 2021: 48
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Phototherapy System (DUV-COMBO) (K254234)Choyang Medics Co., Ltd.2026-05-01
Klär Lite (RCW-KL1000) (K253871)Radcliffe Watts, LLC2026-03-04
Ultraviolet Phototherapy Device (K250425)APK Technology Co., Ltd.2025-04-07
308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (K244022)Boston Aesthetics, Inc.2025-03-13
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (K242977)Xuzhou Kernel Medical Equipment Co., Ltd.2025-02-06
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) (K242908)Shanghai Sigma High-Tech Co., Ltd.2024-12-19
DT Controlled Phototherapy Equipment (K233811)Daavlin Distributing Co.2023-12-13
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) (K223882)Shenzhen Honpal Optoelectronic Technology Co., Ltd.2023-03-27
3 Series NeoLux (K230382)Daavlin Distributing Co.2023-03-24
Enhanced AURORA™ Medical Diode System, and related accessories (K230076)Psoria-Shield, Inc.2023-03-08
1 Series Phototherapy Equipment (K220840)Daavlin Distributing Co.2022-04-22
i8 Tanning Booth (K210004)Ultrasun International B.V.2021-12-10
7 Series Phototherapy Device (K212510)Daavlin Distributing Co.2021-11-04
M Series Phototherapy Equipment (K210881)Daavlin Distributing Co.2021-06-22
308nm Excimer UV-light Skin Therapy System (K202827)Shenzhen Gsd Tech Co., Ltd.2020-12-15
308nm Excimer System (K200971)Xuzhou Kernel Medical Equipment Co., Ltd.2020-12-15
Psoria-Shield AURORA (K192411)Psoria-Shield2020-07-02
308nm Excimer System (K192642)Chongqing Peninsula Medical Technology Co., Ltd.2020-05-13
UV Radiation Treatment System (K191571)Xuzhou Yongkang Electronic Science Technology Co., Ltd.2020-02-06
Exciplex (K191086)Clarteis2019-12-11
UV Phototherapy (K181805)Xuzhou Kernel Medical Equipment Co., Ltd.2019-01-11
ClearLink Controlled Phototherapy Equipment (K182215)Daavlin Distributing Company2018-10-29
308nm Excimer System (K172273)Chongqing Peninsula Medical Technology Co., Ltd.2018-07-30
Luma Light System (K173436)Luma Therapeutics2018-01-30
Exciplex308nm (K171702)Clarteis2017-10-13
Skylit Phototherapy System (K170489)Skylit Medical2017-05-23
3 Series Phototherapy Unit (K153749)Daavlin Distributing Company2016-06-30
ML24000 UVA-1 Phototherapy Cabinet (K151795)Daavlin Distributing Co.2015-09-10
GME ExSys 308 (K150752)Gme (German Medical Engineering) GmbH2015-07-31
Houva-NET Control System (K150912)National Biological Corporation2015-07-10
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL (K134009)Medtek Lighting2014-10-15
UV PHOTOTHERAPY (K132643)Xuzhou Kernel Medical Equipment Co., Ltd.2014-01-30
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS (K130519)Philips Lighting Company2013-12-24
MOBILE VERSA LIGHT (K111049)Medtek Lighting Corp2012-05-25
SMART TOUCH UVTHERAPY MULTIPLE MACHINE (K110912)Daavlin Distributing Co.2011-10-20
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES (K111172)Daavlin Distributing Co.2011-08-29
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY (K103204)Solarc Systems, Inc.2011-04-27
ML24000 UVA-1 PHOTOTHERAPY UNIT (K103708)The Daavlin Distributing Company2011-02-22
PSORIA-LIGHT (K103540)Psoria-Shield, Inc.2011-02-10
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 (K100378)Daavlin Distributing Co.2010-04-28
LH-75 PHOTOTHERAPY SYSTEM (K091568)Lerner Medical Devices, Inc.2009-11-05
LH-75T PHOTOTHERAPY SYSTEM (K090097)Lerner Medical Devices, Inc.2009-02-26
ML24000 UVA-1 PHOTOTHERAPY CABINET (K082731)Daavlin Distributing Co.2008-12-17
VERSA LITE (K073503)Diomedics, Inc.2008-01-23
DERMAPAL WITH DIGITAL TIMER (K073587)Daavlin Distributing Co.2008-01-18
308 DERMATOLOGICAL EXCIMER SYSTEM (K073066)Quantel Medical, Inc.2007-12-26
RESOLVE UVB PHOTOTHERAPY SYSTEM (K072035)Allux Medical2007-10-16
PANOSOL II TRU-BLU, MODEL UBL-417 (K070934)National Biological Corp.2007-05-22
3 SERIES PHOTOTHERAPY CABINET (K063621)Daavlin Co.2007-01-17
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY (K061589)Solarc Systems, Inc.2006-08-04
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 (K061295)Theralight, Inc.2006-05-25
UVBIOTEK MODELS 3200B AND 4000B (K051330)Medtek Lighting Corporation2005-11-18
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO (K052660)The Richmond Light Co.2005-10-17
CYNOSUREA ECLILITE AND ECLILITE U (K050080)Cynosure, Inc.2005-05-05
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT (K050695)Daavlin Distributing Co.2005-04-19
3 SERIES PHOTOTHERAPY CABINET (K042502)Daavlin Distributing Co.2004-10-14
HOUVA 3 PHOTOTHERAPY SYSTEM (K041212)National Biological Corp.2004-06-09
LOVELY SYSTEM (K033946)Msq (M2) , Ltd.2004-04-05
LEVIA PHOTOTHERAPY SYSTEM (K040062)Lerner Medical Devices, Inc.2004-02-13
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: (K031800)Solarc Systems, Inc.2003-09-10
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM (K024020)Theralight, Inc.2003-01-17
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ (K022104)Daavlin Distributing Co.2002-09-10
BCLEAR (K021762)Lumenis, Inc.2002-08-23
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 (K022165)Theralight, Inc.2002-07-18
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B (K021092)Philips Lighting Co.2002-05-16
PHILIPS PLS9W/12/2P UVB (K021514)Philips Lighting Co.2002-05-16
BCLEAR (K020591)Lumenis2002-05-16
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM (K011197)Lumenis2001-12-14
HANDISOL WOUND HEALING (K982082)National Biological Corp.1998-10-28
PHOTOTHERAPEUTIX MODEL 2480AB (K935525)Avex Industries , Ltd.1995-05-19
PHOTOTHERAPEUTIX MODEL 2400B (K933954)Avex Industries , Ltd.1995-02-21
PHOTOTHERAPEUTIX MODEL 1650B (K933953)Avex Industries , Ltd.1995-02-21
PHOTOTHERAPEUTIX MODEL 800B (K933952)Avex Industries , Ltd.1995-02-21
PHOTOTHERAPEUTIX MODEL 1600B (K935526)Avex Industries , Ltd.1995-02-17
PHOTOTHERAPEUTIX MODEL 3200A (K935524)Avex Industries , Ltd.1995-02-17
SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT (K935572)Solarc Systems, Inc.1994-03-07
TL 20W/12/RS & TL 40W/12/RS (K935840)Philips Lighting Co.1994-02-24
UVISOL AND UVISOL II (K934808)National Biological Corp.1993-12-16
ESB 2400 SEI (K933146)Esb, Inc., Div. of Ray-O-Vac1993-09-23
PSORALITE (K930856)Daavlin Co.1993-08-26
PHOTOTHERAPY TIMER (K924969)National Biological Corp.1993-02-23
FREE SUN PRO DESIGN 3000 AND 3800 (K925171)Free Sun Prod. AB1992-12-29
HANDISOL (K924077)National Biological Corp.1992-11-20
TL100W/12 (K922963)Philips Lighting Co.1992-09-02
MEDICAL SUNLAMP FOR PHOTOTHERAPY (K915426)American Sunlight, Inc.1992-03-04
PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT (K913760)Psoralite Corp.1991-10-28
TL100W/01 UVB LAMP (K910767)Philips Lighting Co.1991-05-23
PANOSOL II UVA-218 (K904426)National Biological Corp.1990-12-24
PANOSOL II UVB-206 (K904427)National Biological Corp.1990-12-24
PANOSOL II UAB-228 (K904428)National Biological Corp.1990-12-24
MODEL 6/01 UV-B FIXTURE (K904425)Strato-Ray Co.1990-11-21
U.V. SUNLAMP 95UF-II (K901324)Light Sources, Inc.1990-04-26
FLUORESCENT T12 UVA LAMP (K900649)Light Sources, Inc.1990-03-28
U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC) (K900693)Light Sources, Inc.1990-03-27
ALISUN SUNTANNING BED (K896831)Alisun America, Ltd.1989-12-27
SUNTANNING BED, INC. T12 UVA TANNING LAMPS (K896191)Sunbronze1989-12-27
REMINGTON TANFASTIC HANDHELD TANNING WAND (K895410)Remington Products Company, LLC1989-11-27
HOUVA II UVA/UVB (K885029)National Biological Corp.1989-06-02
HOUVA II UVB (K885026)National Biological Corp.1989-06-02
PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000 (K890084)Psoralite Corp.1989-05-11
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