Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP— 510(k) K220138

Substantially Equivalent

Led Spa

FDA 510(k) clearance K220138 for Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP, Substantially Equivalent on 2022-10-05. Applicant: Led Spa.

Clearance details

Applicant: Led Spa
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2022-01-18
Decision date: 2022-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aprilia, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.