Cabinet, Phototherapy (puva)

Product Code: KGL

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 KGL

5711Cabinet, Phototherapy (puva)Ultraviolet Lamp For Dermatologic Disorders.

Total Product Life Cycle (TPLC) Devices

5711Cabinet, Phototherapy (puva)Ultraviolet Lamp For Dermatologic Disorders.

Pre-market Notifications for KGL

K852575WALDMANN F85/100W PUVASYLVANIA LIGHTING PRODUCTS
K841795UV 8001K, PUVA 800, PUVA 180/200 1000WALDMANN LIGHTING CO.
K820280SPECTRA 305/350ULTRALITE
K810668HO-B-LITE VI UNITNATIONAL BIOLOGICAL CORP.
K810358PHOTOTHERAPY LIGHT CHAMBERPAUL B. ELDER CO.
K791977PSORALITE MARK IPAUL B. ELDER CO.
K791116PSORALITE SERIES 30,000PAUL B. ELDER CO.
K761094UVA PHOTOTHERAPY SYSTEMDERMATRON CORP.

Maude Adverse Events

HOUVA 4NATIONAL BIOLOGICAL CORP.2015-05-28
HOUVA IIINATIONAL BIOLOGICAL CORP.2015-01-14
ULTRALITE PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC.2012-12-10
ULTRALITE 680S PHOTOTHERAPY UNITULTRALITE ENTERPRISES INC.2012-10-31
NARROW BAND UVBDARVLIN2007-02-22
OHMEDA PHOTOTHERAPY LIGHTBURTON MEDICAL PRODUCTS2006-05-12
ULTRALITE FULL BODYULTRALITE ENT., INC.2006-04-05
ULTRALITE FULL BODY PHOTOTHERAPY UNULTRALITE ENTERPRISES, INC2005-10-26
HOUVA II PHOTOTHERAPY SYSTEMNATIONAL BIOLOGICAL CORP.2004-05-11
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC.2004-04-08
OHMEDA PHOTOTHERAPY LIGHTOHMEDA MEDICAL, (PART OF GE MEDICAL SYSTEMS)2003-12-24
ULTRALITE HAND/FOOT 1200DULTRALITE ENTERPRISES, INC.2003-10-28
***2003-07-30
ULTRALITEULTRALITE ENTERPRISES2003-06-12
*PHOTOTHERAPY CABINETULTRALITE ENTERPRISES, INC.2002-11-05
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES INC.2002-04-02
PERCLOSEABBOTT LABORATORIES COMP2002-03-25
UVAR XTS PHOTOPHERESIS SYSTEMTHERAKOS, INC.2002-02-27
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC2001-08-31
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC.2001-08-31
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC.2001-07-03
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC2001-07-03
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC2001-07-03
ULTRALITE FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC2001-07-03
ULTRALITE 6809 FULL BODY PHOTOTHERAPY UNITULTRALITE ENTERPRISES, INC2001-06-01
HAND/FOOT IINATIONAL BIOLOGICAL CORP.1996-01-18
HAND/FOOT IINATIONAL BIOLOGICAL CORP.1996-01-18
PHOTOTHERAPY BOOTHDERMA CONTROL, INC.1996-01-04
HOUVA-LIFE COMBINATION UNITNATIONAL BIOLOGICAL CORP.1995-12-20
PHOTOTHERAPY CHAMBERULTRALITE ENTERPRISES, INC.1995-05-01
DAAVLIN SPECTRA 305/350 PHOTOTHERAPY UNITDAAVLIN COMPANY1994-08-04
PSORALITE COM FLEX JOULEE 4.1PSORALITE CORPORATION1992-03-26

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