510(k) K241092— Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT

Substantially Equivalent

Quanta System Spa

Clearance details

Applicant: Quanta System Spa
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2024-04-22
Decision date: 2024-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Samarate, IT

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.