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
SUBSCRIBE / SIGN IN
K828585Substantially Equivalent

Opthalas Photocoagulator

Synemed, Inc., Benicia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828585 is the FDA 510(k) clearance record for OPTHALAS PHOTOCOAGULATOR, cleared for Synemed, Inc. on . FDA records list 8 510(k) clearances for Synemed, Inc., from to . As of , FDA records show no recalls naming K828585.

Clearance record

Decision date
Received
(41 days to decision)
Review panel
Unknown
Applicant
Synemed, Inc. 4562 E. Second St., Suite D, Benicia CA
Third party review
No