FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K072035 |
ALLUX MEDICAL |
RESOLVE UVB PHOTOTHERAPY SYSTEM |
10/16/2007 |
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 |
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 |
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 |
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 |