Picosecond Laser System (Model PS10-A and PS10-B)— 510(k) K220268

Substantially Equivalent

Beijing Adss Development Co., Ltd.

FDA 510(k) clearance K220268 for Picosecond Laser System (Model PS10-A and PS10-B), Substantially Equivalent on 2022-08-23. Applicant: Beijing Adss Development Co., Ltd..

Clearance details

Applicant: Beijing Adss Development Co., Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2022-01-31
Decision date: 2022-08-23
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.