510(k) K260690— LumiGlam Laser System (SHE-LSP601-3)

Substantially Equivalent

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: 2026-03-03
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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.