FDA 510(k) Applications for Medical Device Product Code "FTC"
(Light, Ultraviolet, Dermatological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K072035 | ALLUX MEDICAL | RESOLVE UVB PHOTOTHERAPY SYSTEM | 10/16/2007 |
| K250425 | APK Technology Co., Ltd. | Ultraviolet Phototherapy Device | 04/07/2025 |
| K244022 | Boston Aesthetics INC | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | 03/13/2025 |
| K172273 | Chongqing Peninsula Medical Technology Co., Ltd. | 308nm Excimer System | 07/30/2018 |
| K192642 | Chongqing Peninsula Medical Technology Co., Ltd. | 308nm Excimer System | 05/13/2020 |
| K191086 | Clarteis | Exciplex | 12/11/2019 |
| K171702 | Clarteis | Exciplex308nm | 10/13/2017 |
| K050080 | CYNOSURE, INC. | CYNOSUREA ECLILITE AND ECLILITE U | 05/05/2005 |
| K063621 | DAAVLIN CO. | 3 SERIES PHOTOTHERAPY CABINET | 01/17/2007 |
| K100378 | DAAVLIN DISTRIBUTING CO. | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 | 04/28/2010 |
| K220840 | Daavlin Distributing Co. | 1 Series Phototherapy Equipment | 04/22/2022 |
| K230382 | Daavlin Distributing Co. | 3 Series NeoLux | 03/24/2023 |
| K042502 | DAAVLIN DISTRIBUTING CO. | 3 SERIES PHOTOTHERAPY CABINET | 10/14/2004 |
| K111172 | DAAVLIN DISTRIBUTING CO. | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | 08/29/2011 |
| K212510 | Daavlin Distributing Co. | 7 Series Phototherapy Device | 11/04/2021 |
| K073587 | DAAVLIN DISTRIBUTING CO. | DERMAPAL WITH DIGITAL TIMER | 01/18/2008 |
| K022104 | DAAVLIN DISTRIBUTING CO. | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ | 09/10/2002 |
| K233811 | Daavlin Distributing Co. | DT Controlled Phototherapy Equipment | 12/13/2023 |
| K050695 | DAAVLIN DISTRIBUTING CO. | FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT | 04/19/2005 |
| K210881 | Daavlin Distributing Co. | M Series Phototherapy Equipment | 06/22/2021 |
| K082731 | DAAVLIN DISTRIBUTING CO. | ML24000 UVA-1 PHOTOTHERAPY CABINET | 12/17/2008 |
| K151795 | DAAVLIN DISTRIBUTING CO. | ML24000 UVA-1 Phototherapy Cabinet | 09/10/2015 |
| K110912 | DAAVLIN DISTRIBUTING CO. | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | 10/20/2011 |
| K153749 | DAAVLIN DISTRIBUTING COMPANY | 3 Series Phototherapy Unit | 06/30/2016 |
| K182215 | Daavlin Distributing Company | ClearLink Controlled Phototherapy Equipment | 10/29/2018 |
| K073503 | DIOMEDICS, INC. | VERSA LITE | 01/23/2008 |
| K150752 | GME (GERMAN MEDICAL ENGINEERING) GMBH | GME ExSys 308 | 07/31/2015 |
| K040062 | LERNER MEDICAL DEVICES, INC. | LEVIA PHOTOTHERAPY SYSTEM | 02/13/2004 |
| K091568 | LERNER MEDICAL DEVICES, INC. | LH-75 PHOTOTHERAPY SYSTEM | 11/05/2009 |
| K090097 | LERNER MEDICAL DEVICES, INC. | LH-75T PHOTOTHERAPY SYSTEM | 02/26/2009 |
| K173436 | Luma Therapeutics | Luma Light System | 01/30/2018 |
| K020591 | LUMENIS | BCLEAR | 05/16/2002 |
| K011197 | LUMENIS | DERMACLEAR UV-B PHOTOTHERAPY SYSTEM | 12/14/2001 |
| K021762 | LUMENIS, INC. | BCLEAR | 08/23/2002 |
| K134009 | MEDTEK LIGHTING | UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL | 10/15/2014 |
| K111049 | MEDTEK LIGHTING CORP | MOBILE VERSA LIGHT | 05/25/2012 |
| K051330 | MEDTEK LIGHTING CORPORATION | UVBIOTEK MODELS 3200B AND 4000B | 11/18/2005 |
| K033946 | MSQ (M2) LTD. | LOVELY SYSTEM | 04/05/2004 |
| K982082 | NATIONAL BIOLOGICAL CORP. | HANDISOL WOUND HEALING | 10/28/1998 |
| K041212 | NATIONAL BIOLOGICAL CORP. | HOUVA 3 PHOTOTHERAPY SYSTEM | 06/09/2004 |
| K070934 | NATIONAL BIOLOGICAL CORP. | PANOSOL II TRU-BLU, MODEL UBL-417 | 05/22/2007 |
| K150912 | National Biological Corporation | Houva-NET Control System | 07/10/2015 |
| K021514 | PHILIPS LIGHTING CO. | PHILIPS PLS9W/12/2P UVB | 05/16/2002 |
| K021092 | PHILIPS LIGHTING CO. | PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B | 05/16/2002 |
| K130519 | PHILIPS LIGHTING COMPANY | PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS | 12/24/2013 |
| K192411 | Psoria-Shield | Psoria-Shield AURORA | 07/02/2020 |
| K103540 | PSORIA-SHIELD INC. | PSORIA-LIGHT | 02/10/2011 |
| K230076 | Psoria-Shield, Inc. | Enhanced AURORAÖ Medical Diode System, and related accessories | 03/08/2023 |
| K073066 | QUANTEL MEDICAL, INC. | 308 DERMATOLOGICAL EXCIMER SYSTEM | 12/26/2007 |
| K242908 | Shanghai SIGMA High-tech Co., Ltd. | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | 12/19/2024 |
| K202827 | Shenzhen GSD Tech Co., Ltd. | 308nm Excimer UV-light Skin Therapy System | 12/15/2020 |
| K223882 | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | 03/27/2023 |
| K170489 | Skylit Medical | Skylit Phototherapy System | 05/23/2017 |
| K103204 | SOLARC SYSTEMS INC. | SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY | 04/27/2011 |
| K061589 | SOLARC SYSTEMS, INC. | SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY | 08/04/2006 |
| K031800 | SOLARC SYSTEMS, INC. | SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: | 09/10/2003 |
| K103708 | THE DAAVLIN DISTRIBUTING COMPANY | ML24000 UVA-1 PHOTOTHERAPY UNIT | 02/22/2011 |
| K052660 | THE RICHMOND LIGHT CO. | MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO | 10/17/2005 |
| K024020 | THERALIGHT, INC. | THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM | 01/17/2003 |
| K022165 | THERALIGHT, INC. | THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 | 07/18/2002 |
| K061295 | THERALIGHT, INC. | VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 | 05/25/2006 |
| K210004 | Ultrasun International B.V. | i8 Tanning Booth | 12/10/2021 |
| K242977 | Xuzhou Kernel Medical Equipment Co., Ltd. | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | 02/06/2025 |
| K200971 | Xuzhou Kernel Medical Equipment Co., Ltd. | 308nm Excimer System | 12/15/2020 |
| K181805 | Xuzhou Kernel Medical Equipment Co., LTD. | UV Phototherapy | 01/11/2019 |
| K132643 | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | UV PHOTOTHERAPY | 01/30/2014 |
| K191571 | Xuzhou Yongkang Electronic Science Technology Co., Ltd | UV Radiation Treatment System | 02/06/2020 |
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