K253828
- 510(k) number
- K253828
- Device name
- Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
- Applicant
- Beijing HuaCheng Taike Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-02-27
- Date received
- 2025-12-01
- 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: K253828.pdf
Official FDA record: K253828
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.