SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE— 510(k) K921671

Substantially Equivalent

Surgical Products Corp.

FDA 510(k) clearance K921671 for SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE, Substantially Equivalent on 1992-06-18. Applicant: Surgical Products Corp..

Clearance details

Applicant: Surgical Products Corp.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1992-04-08
Decision date: 1992-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.