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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K828194Substantially Equivalent

Laser Laparoscope

Laser Industries, Ltd., Tel Aviv, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828194 is the FDA 510(k) clearance record for LASER LAPAROSCOPE, cleared for Laser Industries , Ltd. on . FDA records list 20 510(k) clearances for Laser Industries , Ltd., from to . As of , FDA records show no recalls naming K828194.

Clearance record

Decision date
Received
(27 days to decision)
Review panel
Unknown
Applicant
Laser Industries , Ltd. Science Based Industrial Park, Tel Aviv, IL
Third party review
No