FDA Product Code
FDA Product Code FTC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4630
510(k) Clearances — 272 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | 2026-05-01 | Traditional | PDF ↗ |
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | 2026-03-04 | Traditional | PDF ↗ |
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | 2025-04-07 | Traditional | PDF ↗ |
| 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) | Boston Aesthetics, Inc. | 2025-03-13 | Traditional | PDF ↗ |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 | Traditional | PDF ↗ |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. | 2024-12-19 | Traditional | PDF ↗ |
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2023-12-13 | Special | PDF ↗ |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | 2023-03-27 | Traditional | PDF ↗ |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023-03-24 | Special | PDF ↗ |
| K230076 | Enhanced AURORA Medical Diode System, and related accessories | Psoria-Shield, Inc. | 2023-03-08 | Traditional | PDF ↗ |
| K220840 | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | 2022-04-22 | Special | PDF ↗ |
| K210004 | i8 Tanning Booth | Ultrasun International B.V. | 2021-12-10 | Traditional | PDF ↗ |
| K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | 2021-11-04 | Traditional | PDF ↗ |
| K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021-06-22 | Traditional | PDF ↗ |
| K202827 | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | 2020-12-15 | Traditional | PDF ↗ |
| K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-12-15 | Traditional | PDF ↗ |
| K192411 | Psoria-Shield AURORA | Psoria-Shield | 2020-07-02 | Special | PDF ↗ |
| K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020-05-13 | Traditional | PDF ↗ |
| K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2020-02-06 | Traditional | PDF ↗ |
| K191086 | Exciplex | Clarteis | 2019-12-11 | Traditional | PDF ↗ |
| K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-01-11 | Traditional | PDF ↗ |
| K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018-10-29 | Traditional | PDF ↗ |
| K172273 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2018-07-30 | Traditional | PDF ↗ |
| K173436 | Luma Light System | Luma Therapeutics | 2018-01-30 | Traditional | PDF ↗ |
| K171702 | Exciplex308nm | Clarteis | 2017-10-13 | Traditional | PDF ↗ |
| K170489 | Skylit Phototherapy System | Skylit Medical | 2017-05-23 | Traditional | PDF ↗ |
| K153749 | 3 Series Phototherapy Unit | Daavlin Distributing Company | 2016-06-30 | Special | PDF ↗ |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | Daavlin Distributing Co. | 2015-09-10 | Special | PDF ↗ |
| K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015-07-31 | Traditional | PDF ↗ |
| K150912 | Houva-NET Control System | National Biological Corporation | 2015-07-10 | Traditional | PDF ↗ |
| K134009 | UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL | Medtek Lighting | 2014-10-15 | Traditional | PDF ↗ |
| K132643 | UV PHOTOTHERAPY | Xuzhou Kernel Medical Equipment Co., Ltd. | 2014-01-30 | Traditional | PDF ↗ |
| K130519 | PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS | Philips Lighting Company | 2013-12-24 | Traditional | PDF ↗ |
| K111049 | MOBILE VERSA LIGHT | Medtek Lighting Corp | 2012-05-25 | Traditional | PDF ↗ |
| K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | Daavlin Distributing Co. | 2011-10-20 | Traditional | PDF ↗ |
| K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | Daavlin Distributing Co. | 2011-08-29 | Traditional | PDF ↗ |
| K103204 | SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY | Solarc Systems, Inc. | 2011-04-27 | Traditional | PDF ↗ |
| K103708 | ML24000 UVA-1 PHOTOTHERAPY UNIT | The Daavlin Distributing Company | 2011-02-22 | Traditional | PDF ↗ |
| K103540 | PSORIA-LIGHT | Psoria-Shield, Inc. | 2011-02-10 | Traditional | PDF ↗ |
| K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 | Daavlin Distributing Co. | 2010-04-28 | Traditional | PDF ↗ |
| K091568 | LH-75 PHOTOTHERAPY SYSTEM | Lerner Medical Devices, Inc. | 2009-11-05 | Traditional | PDF ↗ |
| K090097 | LH-75T PHOTOTHERAPY SYSTEM | Lerner Medical Devices, Inc. | 2009-02-26 | Traditional | PDF ↗ |
| K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET | Daavlin Distributing Co. | 2008-12-17 | Traditional | PDF ↗ |
| K073503 | VERSA LITE | Diomedics, Inc. | 2008-01-23 | Traditional | PDF ↗ |
| K073587 | DERMAPAL WITH DIGITAL TIMER | Daavlin Distributing Co. | 2008-01-18 | Traditional | PDF ↗ |
| K073066 | 308 DERMATOLOGICAL EXCIMER SYSTEM | Quantel Medical, Inc. | 2007-12-26 | Traditional | PDF ↗ |
| K072035 | RESOLVE UVB PHOTOTHERAPY SYSTEM | Allux Medical | 2007-10-16 | Traditional | PDF ↗ |
| K070934 | PANOSOL II TRU-BLU, MODEL UBL-417 | National Biological Corp. | 2007-05-22 | Traditional | PDF ↗ |
| K063621 | 3 SERIES PHOTOTHERAPY CABINET | Daavlin Co. | 2007-01-17 | Traditional | PDF ↗ |
| K061589 | SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY | Solarc Systems, Inc. | 2006-08-04 | Traditional | PDF ↗ |
| K061295 | VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 | Theralight, Inc. | 2006-05-25 | Special | PDF ↗ |
| K051330 | UVBIOTEK MODELS 3200B AND 4000B | Medtek Lighting Corporation | 2005-11-18 | Traditional | PDF ↗ |
| 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 | The Richmond Light Co. | 2005-10-17 | Traditional | PDF ↗ |
| K050080 | CYNOSUREA ECLILITE AND ECLILITE U | Cynosure, Inc. | 2005-05-05 | Traditional | PDF ↗ |
| K050695 | FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT | Daavlin Distributing Co. | 2005-04-19 | Traditional | PDF ↗ |
| K042502 | 3 SERIES PHOTOTHERAPY CABINET | Daavlin Distributing Co. | 2004-10-14 | Traditional | PDF ↗ |
| K041212 | HOUVA 3 PHOTOTHERAPY SYSTEM | National Biological Corp. | 2004-06-09 | Special | PDF ↗ |
| K033946 | LOVELY SYSTEM | Msq (M2) , Ltd. | 2004-04-05 | Traditional | PDF ↗ |
| K040062 | LEVIA PHOTOTHERAPY SYSTEM | Lerner Medical Devices, Inc. | 2004-02-13 | Traditional | PDF ↗ |
| K031800 | SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: | Solarc Systems, Inc. | 2003-09-10 | Traditional | PDF ↗ |
| K024020 | THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM | Theralight, Inc. | 2003-01-17 | Traditional | PDF ↗ |
| K022104 | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ | Daavlin Distributing Co. | 2002-09-10 | Traditional | PDF ↗ |
| K021762 | BCLEAR | Lumenis, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K022165 | THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 | Theralight, Inc. | 2002-07-18 | Traditional | PDF ↗ |
| K021514 | PHILIPS PLS9W/12/2P UVB | Philips Lighting Co. | 2002-05-16 | Traditional | PDF ↗ |
| K020591 | BCLEAR | Lumenis | 2002-05-16 | Traditional | PDF ↗ |
| K021092 | PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B | Philips Lighting Co. | 2002-05-16 | Traditional | PDF ↗ |
| K011197 | DERMACLEAR UV-B PHOTOTHERAPY SYSTEM | Lumenis | 2001-12-14 | Traditional | PDF ↗ |
| K982082 | HANDISOL WOUND HEALING | National Biological Corp. | 1998-10-28 | Traditional | PDF ↗ |
| K935525 | PHOTOTHERAPEUTIX MODEL 2480AB | Avex Industries , Ltd. | 1995-05-19 | Traditional | PDF ↗ |
| K933952 | PHOTOTHERAPEUTIX MODEL 800B | Avex Industries , Ltd. | 1995-02-21 | Traditional | PDF ↗ |
| K933953 | PHOTOTHERAPEUTIX MODEL 1650B | Avex Industries , Ltd. | 1995-02-21 | Traditional | PDF ↗ |
| K933954 | PHOTOTHERAPEUTIX MODEL 2400B | Avex Industries , Ltd. | 1995-02-21 | Traditional | PDF ↗ |
| K935524 | PHOTOTHERAPEUTIX MODEL 3200A | Avex Industries , Ltd. | 1995-02-17 | Traditional | PDF ↗ |
| K935526 | PHOTOTHERAPEUTIX MODEL 1600B | Avex Industries , Ltd. | 1995-02-17 | Traditional | PDF ↗ |
| K935572 | SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT | Solarc Systems, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K935840 | TL 20W/12/RS & TL 40W/12/RS | Philips Lighting Co. | 1994-02-24 | Traditional | PDF ↗ |
| K934808 | UVISOL AND UVISOL II | National Biological Corp. | 1993-12-16 | Traditional | PDF ↗ |
| K933146 | ESB 2400 SEI | Esb, Inc., Div. of Ray-O-Vac | 1993-09-23 | Traditional | PDF ↗ |
| K930856 | PSORALITE | Daavlin Co. | 1993-08-26 | Traditional | PDF ↗ |
| K924969 | PHOTOTHERAPY TIMER | National Biological Corp. | 1993-02-23 | Traditional | PDF ↗ |
| K925171 | FREE SUN PRO DESIGN 3000 AND 3800 | Free Sun Prod. AB | 1992-12-29 | Traditional | PDF ↗ |
| K924077 | HANDISOL | National Biological Corp. | 1992-11-20 | Traditional | PDF ↗ |
| K922963 | TL100W/12 | Philips Lighting Co. | 1992-09-02 | Traditional | PDF ↗ |
| K915426 | MEDICAL SUNLAMP FOR PHOTOTHERAPY | American Sunlight, Inc. | 1992-03-04 | Traditional | PDF ↗ |
| K913760 | PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT | Psoralite Corp. | 1991-10-28 | Traditional | PDF ↗ |
| K910767 | TL100W/01 UVB LAMP | Philips Lighting Co. | 1991-05-23 | Traditional | PDF ↗ |
| K904427 | PANOSOL II UVB-206 | National Biological Corp. | 1990-12-24 | Traditional | PDF ↗ |
| K904426 | PANOSOL II UVA-218 | National Biological Corp. | 1990-12-24 | Traditional | PDF ↗ |
| K904428 | PANOSOL II UAB-228 | National Biological Corp. | 1990-12-24 | Traditional | PDF ↗ |
| K904425 | MODEL 6/01 UV-B FIXTURE | Strato-Ray Co. | 1990-11-21 | Traditional | PDF ↗ |
| K901324 | U.V. SUNLAMP 95UF-II | Light Sources, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K900649 | FLUORESCENT T12 UVA LAMP | Light Sources, Inc. | 1990-03-28 | Traditional | PDF ↗ |
| K900693 | U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC) | Light Sources, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K896831 | ALISUN SUNTANNING BED | Alisun America, Ltd. | 1989-12-27 | Traditional | PDF ↗ |
| K896191 | SUNTANNING BED, INC. T12 UVA TANNING LAMPS | Sunbronze | 1989-12-27 | Traditional | PDF ↗ |
| K895410 | REMINGTON TANFASTIC HANDHELD TANNING WAND | Remington Products Company, LLC | 1989-11-27 | Traditional | PDF ↗ |
| K885026 | HOUVA II UVB | National Biological Corp. | 1989-06-02 | Traditional | PDF ↗ |
| K885029 | HOUVA II UVA/UVB | National Biological Corp. | 1989-06-02 | Traditional | PDF ↗ |
| K890084 | PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000 | Psoralite Corp. | 1989-05-11 | Traditional | PDF ↗ |
Product code FTC · Class II · General, Plastic Surgery. Data: openFDA.