K252048
- 510(k) number
- K252048
- Device name
- 808nm semiconductor laser hair removal machine
- Applicant
- Xi'An Taibo Electronic Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-02-03
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252048.pdf
Official FDA record: K252048
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.