Cleared Traditional

K832706 - SENSITIVE EYES (FDA 510(k) Clearance)

K832706 · Bausch & Lomb, Inc. · Ophthalmic device
Oct 1983
Decision
53d
Days
-
Risk

K832706 is an FDA 510(k) clearance for the SENSITIVE EYES. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983, 53 days after receiving the submission on August 12, 1983.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K832706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date October 04, 1983
Days to Decision 53 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code HPX - Lens, Contact (polymethylmethacrylate)
Device Class -