Light, Ultraviolet, Dermatological

Product Code: FTC

General & Plastic Surgery Ultraviolet Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4630


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FTC

5522Light, Ultraviolet, DermatologicalUltraviolet Lamp For Dermatologic Disorders.

Total Product Life Cycle (TPLC) Devices

5522Light, Ultraviolet, DermatologicalUltraviolet Lamp For Dermatologic Disorders.

Pre-market Notifications for FTC

K2208401 Series Phototherapy EquipmentDaavlin Distributing Co.
K2125107 Series Phototherapy DeviceDaavlin Distributing Co.
K210004I8 Tanning BoothUltrasun International B.V.
K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.
K192411Psoria-Shield AURORAPsoria-Shield
K191571UV Radiation Treatment SystemXuzhou Yongkang Electronic Science Technology Co., Ltd
K191086ExciplexClarteis
K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company
K181805UV PhototherapyXuzhou Kernel Medical Equipment Co., LTD.
K173436Luma Light SystemLuma Therapeutics
K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.
K171702Exciplex308nmClarteis
K170489Skylit Phototherapy SystemSkylit Medical
K1537493 Series Phototherapy UnitDAAVLIN DISTRIBUTING COMPANY
K151795ML24000 UVA-1 Phototherapy CabinetDAAVLIN DISTRIBUTING CO.

Global Unique Device Identification Database

00672052155344Light, Ultraviolet, Dermatological
00672052155276Light, Ultraviolet, Dermatological
00816878020886Light, Ultraviolet, Dermatological
00816878020879Light, Ultraviolet, Dermatological
00816878020862Light, Ultraviolet, Dermatological
00816878020855Light, Ultraviolet, Dermatological
00816878020848Light, Ultraviolet, Dermatological
00816878020831Light, Ultraviolet, Dermatological
00816878020824Light, Ultraviolet, Dermatological
00816878020817Light, Ultraviolet, Dermatological
00816878020787Light, Ultraviolet, Dermatological
00816878020770Light, Ultraviolet, Dermatological
00816878020763Light, Ultraviolet, Dermatological
00816878020756Light, Ultraviolet, Dermatological
00816878020749Light, Ultraviolet, Dermatological

Maude Adverse Events

PUVAUNK2020-02-21
PSORIA LIGHTPSORIA SHIELD, INC.2019-11-01
YONKER UVB PHOTOTHERAPY INSTRUMENTYONKER MEDICAL2019-09-23
UV RADIOMETERDAAVLIN2019-09-18
UV / PHOTOTHERAPYYONKER MEDICAL2019-08-13
UV / PHOTOTHERAPYYONKER MEDICAL / XUZHOU YONGKANG ELECTRONIC SCIENC2019-08-13
UV PHOTOTHERAPY INSTRUMENTYONKER MEDICAL2019-08-13
YONKER UV PHOTOTHERAPY LAMPXUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO.,2019-08-13
UV PHOTOTHERAPY DEVICEBLUE SCI TECH CO., LTD2019-08-09
UV PHOTOTHERAPY DEVICEBLUE SCITECH CO., LTD.2019-08-06
YONKER PHOTOTHERAPYYONKER MEDICAL2019-07-25
UV / PHOTOTHERAPYYONKER MEDICAL2019-05-21
UV / PHOTOTHERAPYYONKER MEDICAL / XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD2019-05-21
UV PHOTOTHERAPY INSTRUMENTYONKER MEDICAL2019-05-21
HANDISOL IINATIONAL BIOLOGICAL CORP2019-04-10
YONKER PHOTOTHERAPYYONKER MEDICAL2019-04-10
YONKER UV PHOTOTHERAPY LAMPXUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD2019-02-13
YONKER UVB PHOTOTHERAPY INSTRUMENT.2017-06-14
EXCIMER 308ALMA LASERS GMBH2016-06-01
HIGH INTENSITY UVA-1DAAVLIN2016-02-12
PANOSOL 3DNATIONAL BIOLOGICAL CORP.2015-12-07
LEVIA PHOTOTHERAPY SYSTEMDAAVLIN2015-11-18
PANOSOL 3DNATIONAL BIOLOGICAL CORP.2015-09-03
PANOSOL IINATIONAL BIOLOGICAL CORPORATION2015-09-03
UNKNOWNMANUFACTURER UNK2015-06-29
UV ULTRA LIGHTAVEDRO2015-04-07
HOUVA IIINATIONAL BIOLOGICAL CORPORATION2015-03-23
DAAVLINDAAVLIN DISTRIBUTING COMPANY2015-01-28
VITAMIN D LAMPSPERTI KDB2014-10-14
SPERTI VITAMIN D LAMPKBD2013-05-20
DAAVLINDAAVLIN DISTRIBUTING CO.2012-08-15
UV BIOTEKUV BIOTEK2010-08-19
DERMALIGHT 80UV-B WAND / DERMARAT UV-B WANDTOTAL CONTROL PTY. LTD.2010-05-23
MULTILIGHT*2006-08-25
UNKLIGHT BEAM GENERATORUNK2005-02-25
UNKPUVAUNK2004-01-27
MULTILIGHTLUMENIS2002-06-18
ULTRALITE PHOTO THERAPY UNITULTRALITE ENTERPRISES INC2002-05-10
PUVAUNK2001-10-03
UNKNOWN-CLAIMED TO BE WOLFF SYSTEMOSRAM SYLVANIA, INC.1996-12-14
WOLFF SYSTEM EUROSUN S 3OSRAM SYLVANIA, INC.1996-08-12
ULTRAVIOLET LIGHT FIXTUREGUTH LIGHTING1994-09-12
SPECTRA UV THERAPY BOOTHDAAVLIN CO.1994-06-28
PSORALITE COM FLEX JOULEE 4.1PSORALITE CORPORATION1992-07-30
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