Cleared Traditional

K903574 - CHIROFLEX LENS MICROSERT

K903574 is an FDA 510(k) clearance for CHIROFLEX LENS MICROSERT, manufactured by Chiron Ophthalmics. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K903574 · Chiron Ophthalmics · Ophthalmic device
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Sep 1990
Decision
40d
Days
Class 1
Risk

K903574 is an FDA 510(k) clearance for the CHIROFLEX LENS MICROSERT. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on September 17, 1990 after a review of 40 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 Chiron Ophthalmics devices

FDA 510(k) Submission Details - K903574

510(k) Number K903574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date September 17, 1990
Days to Decision 40 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 110d · This submission: 40d
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 K903574.
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