K252745
- 510(k) number
- K252745
- Device name
- Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
- Applicant
- Micro-Energy Medical Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-12-12
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252745.pdf
Official FDA record: K252745
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.