K252427
- 510(k) number
- K252427
- Device name
- Diode Laser Hair Removal Machine (GLD01)
- Applicant
- Sanhe Meditech Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-10-31
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K252427.pdf
Official FDA record: K252427
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.