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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
208 val des bons malades
grand duchy of luxembourg L-212-2121
PMA NumberP050026
Supplement NumberS001
Date Received11/19/2012
Decision Date09/26/2013
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
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.