K232709
- 510(k) number
- K232709
- Device name
- Diode laser therapy device
- Applicant
- Hebei Zhemai Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2023-11-30
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232709.pdf
Official FDA record: K232709
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.