K260765
- 510(k) number
- K260765
- Device name
- Gemini NOVA 810+980 Soft Tissue Laser
- Applicant
- Azena Medical, LLC CA · US
- Product code
- NVK — Laser, Dental, Soft Tissue
- Decision date
- 2026-03-10
- Date received
- 2026-03-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K260765.pdf
Official FDA record: K260765
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.