CHIROFLEX LENS MICROSERT— 510(k) K903574

Name: FDA 510(k) clearance K903574
Creator: U.S. Food and Drug Administration
Published: 1990-09-17

Substantially Equivalent

Chiron Ophthalmics

FDA 510(k) clearance K903574 for CHIROFLEX LENS MICROSERT, Substantially Equivalent on 1990-09-17. Applicant: Chiron Ophthalmics. Device class: 1.

Clearance details

Applicant: Chiron Ophthalmics
Product code: Code KYB
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 1990-08-08
Decision date: 1990-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Chiron Ophthalmics

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K915861 — MEDILENS-CS CORNEAL SHIELD1992-03-06
K914311 — CHIROFLEX II LENS MICROSERT(TM)1992-01-27
K905825 — COLLAGEN SHIELD, VARIOUS MODELS1991-06-10
K903575 — CHIROFLEX FORCEPS1990-12-21
K901880 — MEDILENS(TM) CORNEAL SHIELD1990-07-02

Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.