INNOVATOME MICROKERATOME— 510(k) K973294

Substantially Equivalent

Innovative Optics, Inc.

FDA 510(k) clearance K973294 for INNOVATOME MICROKERATOME, Substantially Equivalent on 1997-10-03. Applicant: Innovative Optics, Inc..

Clearance details

Applicant: Innovative Optics, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1997-09-02
Decision date: 1997-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lilburn, GA, US

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.