510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K832085Substantially Equivalent

Lensometer

CooperVision, Inc., Southampton, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832085 is the FDA 510(k) clearance record for LENSOMETER, cleared for CooperVision, Inc. on . FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K832085.

Clearance record

Decision date
Received
(49 days to decision)
Review panel
Unknown
Applicant
CooperVision, Inc. Permalens House, Southampton, GB
Third party review
No