PICOANDY (Q-Switched Nd:YAG Laser)— 510(k) K234104

Substantially Equivalent

Wontech Co., Ltd.

FDA 510(k) clearance K234104 for PICOANDY (Q-Switched Nd:YAG Laser), Substantially Equivalent on 2024-03-15. Applicant: Wontech Co., Ltd..

Clearance details

Applicant: Wontech Co., Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2023-12-26
Decision date: 2024-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 64, Techno 8-Ro, Yuseong-Gu, 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.