BAUSCH & LOMB NGX MICROSURGICAL SYSTEM— 510(k) K063331

Substantially Equivalent

Bausch & Lomb, Inc.

FDA 510(k) clearance K063331 for BAUSCH & LOMB NGX MICROSURGICAL SYSTEM, Substantially Equivalent on 2006-12-19. Applicant: Bausch & Lomb, Inc..

Clearance details

Applicant: Bausch & Lomb, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2006-11-03
Decision date: 2006-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rochester, 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.