K243957
- 510(k) number
- K243957
- Device name
- PICOALEX
- Applicant
- Wontech Co., Ltd. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-03-12
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243957.pdf
Official FDA record: K243957
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.