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FDA 510(k)

EYE SPHERE, CONFORMERS

K-Number: K972661 · 1997-10-03

ApplicantGulden Ophthalmics
Decision Date1997-10-03
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE SPHERE, CONFORMERS is the device name listed in this FDA 510(k) record. The listed applicant is Gulden Ophthalmics. It received FDA 510(k) clearance on 1997-10-03 under 510(k) number K972661. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE SPHERE, CONFORMERS?

EYE SPHERE, CONFORMERS is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Gulden Ophthalmics. The 510(k) number is K972661.

When did EYE SPHERE, CONFORMERS receive FDA 510(k) clearance?

EYE SPHERE, CONFORMERS received FDA 510(k) clearance on 1997-10-03, under 510(k) number K972661.

Who is the listed applicant for EYE SPHERE, CONFORMERS?

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

What is the FDA product code for EYE SPHERE, CONFORMERS?

The FDA product code for EYE SPHERE, CONFORMERS is HPZ.

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Related Devices (Code: HPZ)

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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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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