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FDA 510(k)

SUN PHOTO-KERATOSCOPE

K-Number: K831084 · 1983-06-30

ApplicantNidek, Inc.
Decision Date1983-06-30
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUN PHOTO-KERATOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831084. 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 SUN PHOTO-KERATOSCOPE?

SUN PHOTO-KERATOSCOPE is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Nidek, Inc.. The 510(k) number is K831084.

When did SUN PHOTO-KERATOSCOPE receive FDA 510(k) clearance?

SUN PHOTO-KERATOSCOPE received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831084.

Who is the listed applicant for SUN PHOTO-KERATOSCOPE?

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

What is the FDA product code for SUN PHOTO-KERATOSCOPE?

The FDA product code for SUN PHOTO-KERATOSCOPE is HLQ.

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Other records listing Nidek, Inc. 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.

K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

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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

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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