AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38— 510(k) K925254

Substantially Equivalent

Allergan Medical Optics

FDA 510(k) clearance K925254 for AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38, Substantially Equivalent on 1993-01-07. Applicant: Allergan Medical Optics.

Clearance details

Applicant: Allergan Medical Optics
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1992-10-19
Decision date: 1993-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anasco, PR, 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.