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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K853927Substantially Equivalent

Lase System II

James L. Geraci & Associates, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853927 is the FDA 510(k) clearance record for LASE SYSTEM II, cleared for James L. Geraci & Associates, Inc. on . FDA records list 5 510(k) clearances for James L. Geraci & Associates, Inc., from to . As of , FDA records show no recalls naming K853927.

Clearance record

Decision date
Received
(22 days to decision)
Review panel
Unknown
Applicant
James L. Geraci & Associates, Inc. P.O. Box 41291, Cincinnati OH
Third party review
No