K234104
- 510(k) number
- K234104
- Device name
- PICOANDY (Q-Switched Nd:YAG Laser)
- Applicant
- Wontech Co., Ltd. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-03-15
- Date received
- 2023-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K234104.pdf
Official FDA record: K234104
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.