PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE— 510(k) K925631

Name: FDA 510(k) clearance K925631
Creator: U.S. Food and Drug Administration
Published: 1993-07-29

Substantially Equivalent

Chiron Intraoptics

FDA 510(k) clearance K925631 for PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE, Substantially Equivalent on 1993-07-29. Applicant: Chiron Intraoptics. Device class: 2.

Clearance details

Applicant: Chiron Intraoptics
Product code: Product code HQC
Device class: Class 2
Regulation: 21 CFR 886.4670
Advisory panel: Ophthalmic
Date received: 1992-11-09
Decision date: 1993-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.