MEDITEC OPL3 ND:YAG LASER

FDA Premarket Approval P830025

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

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 Received1983-06-02
Decision Date1985-01-14
Notice Date1985-02-21
PMAP830025
SupplementS
Product CodeLOI 
Docket Number85M-0038
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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