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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/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.
 
DeviceCOHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
ApplicantLUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104
PMA NumberP940011
Date Received04/13/1994
Decision Date12/27/1995
Withdrawal Date 01/14/2014
Product Code MVF 
Docket Number 97M-0204
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COHERENT PLD1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Supplements:  S001 S003 S002 
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