KGLClass II

Cabinet, Phototherapy (puva)

General, Plastic Surgery · 21 CFR 878.4630

MDR events32All time

Recalls0All time

Registered firms0Currently listed

510(k) clearances8All time

Recent MDR events

32 adverse event reports on file

HOUVA 4May 28, 2015
InjuryNational Biological Corp.1521608-2015-00002
HOUVA IIIJan 14, 2015
InjuryNational Biological Corp.1521608-2014-00001
ULTRALITE PHOTOTHERAPY UNITDec 10, 2012
InjuryUltralite Enterprises, Inc.1045025-2012-00001
ULTRALITE 680S PHOTOTHERAPY UNITOct 31, 2012
InjuryUltralite Enterprises Inc.MW5027456
NARROW BAND UVBFeb 22, 2007
MalfunctionDarvlinMW1042030
OHMEDA PHOTOTHERAPY LIGHTMay 12, 2006
MalfunctionBurton Medical Products2018492-2006-00008
ULTRALITE FULL BODYApr 5, 2006
Ultralite Ent., Inc.1045025-2006-00001
ULTRALITE FULL BODY PHOTOTHERAPY UNOct 26, 2005
OtherUltralite Enterprises, Inc1045025-2005-00001
HOUVA II PHOTOTHERAPY SYSTEMMay 11, 2004
InjuryNational Biological Corp.1521608-2004-00001
ULTRALITE FULL BODY PHOTOTHERAPY UNITApr 8, 2004
InjuryUltralite Enterprises, Inc.1045025-2004-00001

Event type breakdown

Other13

Injury12

Malfunction5

Unspecified2

Most-reported manufacturers

Ultralite Enterprises, Inc.7 National Biological Corp.6 Ultralite Enterprises, Inc6 Ultralite Enterprises Inc.2 *1 Abbott Laboratories Comp1 Burton Medical Products1 Daavlin Company1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

8 clearances for this product code