MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM— 510(k) K955245

Substantially Equivalent

Mentor O & O, Inc.

FDA 510(k) clearance K955245 for MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM, Substantially Equivalent on 1996-02-12. Applicant: Mentor O & O, Inc..

Clearance details

Applicant: Mentor O & O, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1995-11-15
Decision date: 1996-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, 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.