Cleared Traditional

K854197 - IOSERT LENS IMPLANT INSTRUMENT

K854197 is the FDA 510(k) clearance for IOSERT LENS IMPLANT INSTRUMENT by Chiron Vision Corp.. It is a Class 1 Ophthalmic device (product code KYB) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K854197 · Chiron Vision Corp. · Ophthalmic device
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Jan 1986
Decision
99d
Days
Class 1
Risk

K854197 is an FDA 510(k) clearance for the IOSERT LENS IMPLANT INSTRUMENT. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 99 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 Chiron Vision Corp. devices

Submission Details

510(k) Number K854197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date January 22, 1986
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 10
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K854197.
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
SURFACE REPLACEMENT HIP PROSTHESIS
K811718 · Biomet, Inc. · Sep 1981
CEMENT SPACERS
K791351 · Depuy, Inc. · Aug 1979