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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.
 
DeviceQCELLUS LASER
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
VALEANT PHARMACEUTICALS LUXEMBOURG S.A.R.L.
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.
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