SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser— 510(k) K222485

Substantially Equivalent

Ids, Limited

FDA 510(k) clearance K222485 for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser, Substantially Equivalent on 2023-03-29. Applicant: Ids, Limited.

Clearance details

Applicant: Ids, Limited
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2022-08-17
Decision date: 2023-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

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.