Cleared Traditional

K832085 - LENSOMETER (FDA 510(k) Clearance)

Aug 1983
Decision
49d
Days
Risk

K832085 is an FDA 510(k) clearance for the LENSOMETER..

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 16, 1983, 49 days after receiving the submission on June 28, 1983.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K832085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date August 16, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code
Device Class