MEDITEC OPL3 ND:YAG LASER

FDA Premarket Approval P830025 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

DeviceMEDITEC OPL3 ND:YAG LASER
Generic NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
ApplicantMEDICAL LASER, INC.
Date Received1985-02-22
Decision Date1985-06-25
PMAP830025
SupplementS001
Product CodeLOI 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address MEDICAL LASER, INC. 5454 Wisconsin Ave. chevy Chase, MD 20815

Supplemental Filings

Supplement NumberDateSupplement Type
P830025Original Filing
S002 1985-07-29
S001 1985-02-22

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