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FDA 510(k)

KERATOREF L60

K-Number: K922253 · 1992-06-19

ApplicantLuneau Ophtalmologie SA
Decision Date1992-06-19
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KERATOREF L60 is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Ophtalmologie SA. It received FDA 510(k) clearance on 1992-06-19 under 510(k) number K922253. The device is classified under product code HLQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERATOREF L60?

KERATOREF L60 is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is Luneau Ophtalmologie SA. The 510(k) number is K922253.

When did KERATOREF L60 receive FDA 510(k) clearance?

KERATOREF L60 received FDA 510(k) clearance on 1992-06-19, under 510(k) number K922253.

Who is the listed applicant for KERATOREF L60?

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

What is the FDA product code for KERATOREF L60?

The FDA product code for KERATOREF L60 is HLQ.

Related Clinical Trials

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Other records listing Luneau Ophtalmologie SA 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.

K921214OPHTHALMIC PROJECTORK913961OPHTHALMIC STAND

Related Devices (Code: HLQ)

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.

K003299OPD-SCAN, MODELS ARK-10000 AND ARK-9000Nidek Co., Ltd.K973756EYE SYS VISTAEyesys Technologies, Inc.K964290EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical Marketinig

Official Source

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

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