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FDA 510(k)

CHIROFLEX II LENS MICROSERT(TM)

K-Number: K914311 · 1992-01-27

ApplicantChiron Ophthalmics
Decision Date1992-01-27
Product CodeHQL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CHIROFLEX II LENS MICROSERT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Ophthalmics. It received FDA 510(k) clearance on 1992-01-27 under 510(k) number K914311. The device is classified under product code HQL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHIROFLEX II LENS MICROSERT(TM)?

CHIROFLEX II LENS MICROSERT(TM) is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Chiron Ophthalmics. The 510(k) number is K914311.

When did CHIROFLEX II LENS MICROSERT(TM) receive FDA 510(k) clearance?

CHIROFLEX II LENS MICROSERT(TM) received FDA 510(k) clearance on 1992-01-27, under 510(k) number K914311.

Who is the listed applicant for CHIROFLEX II LENS MICROSERT(TM)?

The FDA 510(k) record lists Chiron Ophthalmics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHIROFLEX II LENS MICROSERT(TM)?

The FDA product code for CHIROFLEX II LENS MICROSERT(TM) is HQL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Chiron Ophthalmics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K915861MEDILENS-CS CORNEAL SHIELDK905825COLLAGEN SHIELD, VARIOUS MODELSK903575CHIROFLEX FORCEPSK903574CHIROFLEX LENS MICROSERTK901880MEDILENS(TM) CORNEAL SHIELDK894162OPTISOL

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Related Devices (Code: HQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K913626SOFTRANS INJECTORStaar Surgical Co.K842892NIDEK DIGITAL KERATOMETERNidek, Inc.K842504AMER. MEDICAL OPTICS DIGITAL KERATO-American Medical OpticsK771933CILCO ANTERIOR CHAMBER LENSCalifornia Intraocular Lens

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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