ClearanceBrief
Panels › General, Plastic Surgery › Product code FTC · Class 2

Light, Ultraviolet, Dermatological

Regulation 878.4630

4510(k)s in 12 months (274 all time)
4recalls in 12 months (15 all time)
10recalls that name a 510(k)
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Top companies in FTC

Company510(k)sRecalls
National Biological Corp.274
Daavlin Distributing Co.1711
Philips Int'L B.V.90
Light Sources, Inc.80
Mottek Intl. Corp.80
Avex Industries , Ltd.60
Philips Lighting Co.60
Psoralite Corp.50
Tannhut50
Medical Device Consultants, Inc.40
Decided510(k)Device and applicantCode
Oct 14, 2026K262885308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)
Guangxi Hope Medical Devices Technology Co., Ltd., CN
FTC
Oct 5, 2026K262285UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)
Shijiazhuang Recovery Star Medical Device Co., Ltd., CN
FTC
May 1, 2026K254234Phototherapy System (DUV-COMBO)
Choyang Medics Co., Ltd., KR
FTC
Mar 4, 2026K253871Klär Lite (RCW-KL1000)
Radcliffe Watts, LLC
FTC
Apr 7, 2025K250425Ultraviolet Phototherapy Device
APK Technology Co., Ltd., CN
FTC
Mar 13, 2025K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV
Boston Aesthetics, Inc.
FTC
Feb 6, 2025K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
Xuzhou Kernel Medical Equipment Co., Ltd., CN
FTC
Dec 19, 2024K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Gr
Shanghai Sigma High-Tech Co., Ltd., CN
FTC
Dec 13, 2023K233811DT Controlled Phototherapy Equipment
Daavlin Distributing Co.
FTC
Mar 27, 2023K223882Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
Shenzhen Honpal Optoelectronic Technology Co., Ltd., CN
FTC
Mar 24, 2023K2303823 Series NeoLux
Daavlin Distributing Co.
FTC
Mar 8, 2023K230076Enhanced AURORA™ Medical Diode System, and related accessories
Psoria-Shield, Inc.
FTC
Apr 22, 2022K2208401 Series Phototherapy Equipment
Daavlin Distributing Co.
FTC
Dec 10, 2021K210004i8 Tanning Booth
Ultrasun International B.V., NL
FTC
Nov 4, 2021K2125107 Series Phototherapy Device
Daavlin Distributing Co.
FTC
Jun 22, 2021K210881M Series Phototherapy Equipment
Daavlin Distributing Co.
FTC
Dec 15, 2020K202827308nm Excimer UV-light Skin Therapy System
Shenzhen Gsd Tech Co., Ltd., CN
FTC
Dec 15, 2020K200971308nm Excimer System
Xuzhou Kernel Medical Equipment Co., Ltd., CN
FTC
Jul 2, 2020K192411Psoria-Shield AURORA
Psoria-Shield
FTC
May 13, 2020K192642308nm Excimer System
Chongqing Peninsula Medical Technology Co., Ltd., CN
FTC
Feb 6, 2020K191571UV Radiation Treatment System
Xuzhou Yongkang Electronic Science Technology Co., Ltd., CN
FTC
Dec 11, 2019K191086Exciplex
Clarteis, FR
FTC
Jan 11, 2019K181805UV Phototherapy
Xuzhou Kernel Medical Equipment Co., Ltd., CN
FTC
Oct 29, 2018K182215ClearLink Controlled Phototherapy Equipment
Daavlin Distributing Company
FTC
Jul 30, 2018K172273308nm Excimer System
Chongqing Peninsula Medical Technology Co., Ltd., CN
FTC
Jan 30, 2018K173436Luma Light System
Luma Therapeutics
FTC
Oct 13, 2017K171702Exciplex308nm
Clarteis, FR
FTC
May 23, 2017K170489Skylit Phototherapy System
Skylit Medical
FTC
Jun 30, 2016K1537493 Series Phototherapy Unit
Daavlin Distributing Company
FTC
Sep 10, 2015K151795ML24000 UVA-1 Phototherapy Cabinet
Daavlin Distributing Co.
FTC
Jul 31, 2015K150752GME ExSys 308
Gme (German Medical Engineering) GmbH, DE
FTC
Jul 10, 2015K150912Houva-NET Control System
National Biological Corporation
FTC
Oct 15, 2014K134009UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
Medtek Lighting
FTC
Jan 30, 2014K132643UV PHOTOTHERAPY
Xuzhou Kernel Medical Equipment Co., Ltd., CN
FTC
Dec 24, 2013K130519PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
Philips Lighting Company
FTC
May 25, 2012K111049MOBILE VERSA LIGHT
Medtek Lighting Corp
FTC
Oct 20, 2011K110912SMART TOUCH UVTHERAPY MULTIPLE MACHINE
Daavlin Distributing Co.
FTC
Aug 29, 2011K1111724 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
Daavlin Distributing Co.
FTC
Apr 27, 2011K103204SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
Solarc Systems, Inc., CA
FTC
Feb 22, 2011K103708ML24000 UVA-1 PHOTOTHERAPY UNIT
The Daavlin Distributing Company
FTC
Feb 10, 2011K103540PSORIA-LIGHT
Psoria-Shield, Inc.
FTC
Apr 28, 2010K1003781 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
Daavlin Distributing Co.
FTC
Nov 5, 2009K091568LH-75 PHOTOTHERAPY SYSTEM
Lerner Medical Devices, Inc.
FTC
Feb 26, 2009K090097LH-75T PHOTOTHERAPY SYSTEM
Lerner Medical Devices, Inc.
FTC
Dec 17, 2008K082731ML24000 UVA-1 PHOTOTHERAPY CABINET
Daavlin Distributing Co.
FTC
Jan 23, 2008K073503VERSA LITE
Diomedics, Inc.
FTC
Jan 18, 2008K073587DERMAPAL WITH DIGITAL TIMER
Daavlin Distributing Co.
FTC
Dec 26, 2007K073066308 DERMATOLOGICAL EXCIMER SYSTEM
Quantel Medical, Inc.
FTC
Oct 16, 2007K072035RESOLVE UVB PHOTOTHERAPY SYSTEM
Allux Medical
FTC
May 22, 2007K070934PANOSOL II TRU-BLU, MODEL UBL-417
National Biological Corp.
FTC

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