Cleared Traditional

K941603 - AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE

K941603 is an FDA 510(k) clearance for AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, manufactured by Allergan Medical Optics. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K941603 · Allergan Medical Optics · Ophthalmic device
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Jul 1994
Decision
96d
Days
Class 1
Risk

K941603 is an FDA 510(k) clearance for the AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Allergan Medical Optics (Irvine, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 96 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Allergan Medical Optics devices

FDA 510(k) Submission Details - K941603

510(k) Number K941603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date July 06, 1994
Days to Decision 96 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
14d faster than avg
Panel avg: 110d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

KYB Device Classification - Class 1, General Controls

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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 24
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K941603.
AMO PHACOFLEX II INTERSECTION SYSTEM
K961242 · Allergan, Inc. · Jun 1996
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · Staar Surgical Co. · Dec 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · Chiron Vision Corp. · Jun 1995
KRATZ NOVA-SERT
K871440 · CooperVision, Inc. · May 1987
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265 · CooperVision, Inc. · Feb 1987
SOFT LENS FOLDER
K861990 · Staar Surgical Co. · Jun 1986