Cleared Traditional

K961242 - AMO PHACOFLEX II INTERSECTION SYSTEM

K961242 is an FDA 510(k) clearance for AMO PHACOFLEX II INTERSECTION SYSTEM, manufactured by Allergan, Inc.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961242 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
77d
Days
Class 1
Risk

K961242 is an FDA 510(k) clearance for the AMO PHACOFLEX II INTERSECTION SYSTEM. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on June 17, 1996 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allergan, Inc. devices

FDA 510(k) Submission Details - K961242

510(k) Number K961242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date June 17, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 110d · This submission: 77d
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 19
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K961242.
MONARCH IOL DELIVERY SYSTEM
K981571 · Alcon Laboratories · Jul 1998
MONARCH IOL DELIVERY SYSTEM
K970033 · Alcon Laboratories · Apr 1997
ACRYPAK FOLDER
K965185 · Alcon Laboratories · Mar 1997
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