Cleared Traditional

AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR (K930320) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930320 · Allergan Medical Optics · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
440d
Days
Class 1
Risk

K930320 is an FDA 510(k) clearance for the AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Allergan Medical Optics (Anasco, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 440 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Allergan Medical Optics devices

Submission Details

510(k) Number K930320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date April 07, 1994
Days to Decision 440 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
330d slower than avg
Panel avg: 110d · This submission: 440d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.