PHACO 20/20 SYSTEM I— 510(k) K915457

Substantially Equivalent

Innovative Medical Systems, Inc.

FDA 510(k) clearance K915457 for PHACO 20/20 SYSTEM I, Substantially Equivalent on 1992-02-24. Applicant: Innovative Medical Systems, Inc..

Clearance details

Applicant: Innovative Medical Systems, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1991-12-05
Decision date: 1992-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commack, NY, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.