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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceQCELLUS LASER
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
ApplicantBausch + Lomb Ireland Limited
400 Somerset Corporate Blvd
Bridgewater, NJ 08807
PMA NumberP050026
Supplement NumberS001
Date Received11/19/2012
Decision Date09/26/2013
Product Code MVF 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR: 1) CHANGE IN THE NAME OF THE DEVICE FROM ACTIVIS LASER TO QCELLUS LASER; 2) CHANGE IN THE LASER DESIGN TO COMBINE THE LASER MODULE AND SLIT LAMP ADAPTER INTO A SINGLE UNIT TO BE MOUNTED DIRECTLY ON THE TONOMETER POST OF A HAAG-STREIT 900 BM/BQ SLIT LAMP OR EQUIVALENT; AND 3) CHANGE MANUFACTURING SITE FOR THE QCELLUS LASER TO QLT, INC., VANCOUVER, BC, CANADA.
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