Q-Switched Nd:YAG Laser (SHE-LSP101-1)— 510(k) K250936

Substantially Equivalent

Beijing Sano Laser S&T Development Co.,Ltd

FDA 510(k) clearance K250936 for Q-Switched Nd:YAG Laser (SHE-LSP101-1), Substantially Equivalent on 2025-06-12. Applicant: Beijing Sano Laser S&T Development Co.,Ltd.

Clearance details

Applicant: Beijing Sano Laser S&T Development Co.,Ltd
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2025-03-28
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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.