Cleared Traditional

CHIROFLEX II LENS MICROSERT(TM) (K914311) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

K914311 is an FDA 510(k) clearance for the CHIROFLEX II LENS MICROSERT(TM). Classified as Intraocular Lens (product code HQL), Class III - Premarket Approval.

Submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3600 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Chiron Ophthalmics devices

Submission Details

510(k) Number K914311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 110d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQL Intraocular Lens
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 886.3600
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.