Cleared Traditional

CHIROFLEX II LENS MICROSERT(TM)

K914311 · Chiron Ophthalmics · Ophthalmic
Jan 1992
Decision
123d
Days
Class 3
Risk

About This 510(k) Submission

K914311 is an FDA 510(k) clearance for the CHIROFLEX II LENS MICROSERT(TM), a Intraocular Lens (Class III — Premarket Approval, product code HQL), submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on January 27, 1992, 123 days after receiving the submission on September 26, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3600.

Submission Details

510(k) Number K914311 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1991
Decision Date January 27, 1992
Days to Decision 123 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQL — Intraocular Lens
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 886.3600