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FDA 510(k)

INNOVATOME MICROKERATOME

K-Number: K973294 · 1997-10-03

ApplicantInnovative Optics, Inc.
Decision Date1997-10-03
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INNOVATOME MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Optics, Inc.. It received FDA 510(k) clearance on 1997-10-03 under 510(k) number K973294. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVATOME MICROKERATOME?

INNOVATOME MICROKERATOME is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Innovative Optics, Inc.. The 510(k) number is K973294.

When did INNOVATOME MICROKERATOME receive FDA 510(k) clearance?

INNOVATOME MICROKERATOME received FDA 510(k) clearance on 1997-10-03, under 510(k) number K973294.

Who is the listed applicant for INNOVATOME MICROKERATOME?

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

What is the FDA product code for INNOVATOME MICROKERATOME?

The FDA product code for INNOVATOME MICROKERATOME is HNO.

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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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