CHIROFLEX II LENS MICROSERT(TM)— 510(k) K914311

Name: FDA 510(k) clearance K914311
Creator: U.S. Food and Drug Administration
Published: 1992-01-27

Substantially Equivalent

Chiron Ophthalmics

FDA 510(k) clearance K914311 for CHIROFLEX II LENS MICROSERT(TM), Substantially Equivalent on 1992-01-27. Applicant: Chiron Ophthalmics. Device class: 3.

Clearance details

Applicant: Chiron Ophthalmics
Product code: Code HQL
Device class: Class 3
Regulation: 21 CFR 886.3600
Advisory panel: Ophthalmic
Date received: 1991-09-26
Decision date: 1992-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQL

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K913626 — SOFTRANS INJECTOR1991-12-18
K842892 — NIDEK DIGITAL KERATOMETER1984-10-05
K842504 — AMER. MEDICAL OPTICS DIGITAL KERATO-1984-10-01
K771933 — CILCO ANTERIOR CHAMBER LENS1978-01-26

More clearances from Chiron Ophthalmics

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K915861 — MEDILENS-CS CORNEAL SHIELD1992-03-06
K905825 — COLLAGEN SHIELD, VARIOUS MODELS1991-06-10
K903575 — CHIROFLEX FORCEPS1990-12-21
K903574 — CHIROFLEX LENS MICROSERT1990-09-17
K901880 — MEDILENS(TM) CORNEAL SHIELD1990-07-02

Adverse events under product code HQL

product code HQL

Injury: 7,145
Malfunction: 15,684
Other: 5
Total: 22,834

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.