K260257
- 510(k) number
- K260257
- Device name
- CO2 Laser System
- Applicant
- Sanhe Meditech Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-03-28
- Date received
- 2026-01-28
- 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: K260257.pdf
Official FDA record: K260257
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.