600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS

FDA Premarket Approval P940012

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the 600 series dye modules (models 630 and 630 xp) and series 700 and 800 ktp/532 and ktp/yag (operating at 532 nm) surgical lasers

Device600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
Generic NameSystem, Laser, Photodynamic Therapy
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
Date Received1994-04-13
Decision Date1995-12-27
PMAP940012
SupplementS
Product CodeMVF 
Docket Number97M-0204
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product Yes
Applicant Address AMERICAN MEDICAL SYSTEMS, INC. 10700 Bren Road West minnetonka, MN 55343

Supplemental Filings

Supplement NumberDateSupplement Type
P940012Original Filing
S002 1998-03-24 Normal 180 Day Track
S001 1997-02-11 Normal 180 Day Track

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