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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade Name600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
Classification Namesystem, laser, photodynamic therapy
Generic Namelaser for photodynamic therapy
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP940012
Date Received04/13/1994
Decision Date12/27/1995
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 97M-0204
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
Supplements: S001 S002 
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