Cleared Traditional

MEDILENS-CS CORNEAL SHIELD

K915861 · Chiron Ophthalmics · Ophthalmic
Mar 1992
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K915861 is an FDA 510(k) clearance for the MEDILENS-CS CORNEAL SHIELD, a Collagen Corneal Shield (Class I — General Controls, product code MOE), submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on March 6, 1992, 66 days after receiving the submission on December 31, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number K915861 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1991
Decision Date March 06, 1992
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MOE — Collagen Corneal Shield
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4750

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