CO2 Laser System— 510(k) K221597

Substantially Equivalent

Smedtrum Medical Technology Co., Ltd.

FDA 510(k) clearance K221597 for CO2 Laser System, Substantially Equivalent on 2022-09-15. Applicant: Smedtrum Medical Technology Co., Ltd..

Clearance details

Applicant: Smedtrum Medical Technology Co., Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2022-06-02
Decision date: 2022-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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.