510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K827819Substantially Equivalent

Laser Photocoagulator

American Laser Corp., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827819 is the FDA 510(k) clearance record for LASER PHOTOCOAGULATOR, cleared for American Laser Corp. on . FDA records list 5 510(k) clearances for American Laser Corp., from to . As of , FDA records show no recalls naming K827819.

Clearance record

Decision date
Received
(80 days to decision)
Review panel
Unknown
Applicant
American Laser Corp. 2860 Wilderness Pl., Boulder CO
Third party review
No