PRO-PHACO HANDPIECE— 510(k) K933503

Substantially Equivalent

M. Imonti and Associates Inc.,

FDA 510(k) clearance K933503 for PRO-PHACO HANDPIECE, Substantially Equivalent on 1994-01-06. Applicant: M. Imonti and Associates Inc.,.

Clearance details

Applicant: M. Imonti and Associates Inc.,
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1993-07-19
Decision date: 1994-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

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.