K230047
- 510(k) number
- K230047
- Device name
- Medical Diode Laser Systems
- Applicant
- Gigaalaser Company , Ltd. CN
- Product code
- NVK — Laser, Dental, Soft Tissue
- Decision date
- 2024-03-04
- Date received
- 2023-01-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K230047.pdf
Official FDA record: K230047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.