COHERENT OPAL PHOTOACTIVATOR

System, Laser, Photodynamic Therapy

FDA Premarket Approval P990049 S001

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.

Pre-market Approval Supplement Details

Approval for a revision of the indication for use statement to read "for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. "

DeviceCOHERENT OPAL PHOTOACTIVATOR
Classification NameSystem, Laser, Photodynamic Therapy
Generic NameSystem, Laser, Photodynamic Therapy
ApplicantLUMENIS
Date Received2000-08-16
Decision Date2001-09-27
PMAP990049
SupplementS001
Product CodeMVF
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address LUMENIS 3959 West 1820 South salt Lake City, UT 84104

Supplemental Filings

Supplement NumberDateSupplement Type
P990049Original Filing
S001 2000-08-16 Normal 180 Day Track

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