Cleared Traditional

K981116 - SOVEREIGN CATARACT EXTRACTION SYSTEM

K981116 is the FDA 510(k) clearance for SOVEREIGN CATARACT EXTRACTION SYSTEM by Allergan, Inc.. It is a Class 1 Ophthalmic device (product code KYG) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K981116 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
53d
Days
Class 1
Risk

K981116 is an FDA 510(k) clearance for the SOVEREIGN CATARACT EXTRACTION SYSTEM. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on May 19, 1998 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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

Submission Details

510(k) Number K981116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1998
Decision Date May 19, 1998
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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 - KYG Device, Irrigation, Ocular Surgery

All 8
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K981116.
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
K922996 · Chiron Vision Corp. · Jul 1992
AQUEOUS PARACENTESIS PIPET
K915808 · Visitec Co. · Mar 1992
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · Alcon Laboratories · Jul 1988
VISITEC IRRIGATION CONTROL SYSTEM
K853243 · Visitec Co. · Sep 1985
OPERAID DISPOS. IRRIGATING KNIFE
K845039 · Jedmed Instrument Co. · Mar 1985
OPERAID NUCLEUS
K841807 · Jedmed Instrument Co. · Nov 1984