SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER— 510(k) K031440

Substantially Equivalent

Cynosure, Inc.

FDA 510(k) clearance K031440 for SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER, Substantially Equivalent on 2003-10-01. Applicant: Cynosure, Inc..

Clearance details

Applicant: Cynosure, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2003-05-06
Decision date: 2003-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, 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.