Gemini NOVA 810+980 Soft Tissue Laser— 510(k) K260765
Substantially EquivalentAzena Medical, LLC
FDA 510(k) clearance K260765 for Gemini NOVA 810+980 Soft Tissue Laser, Substantially Equivalent on 2026-03-10. Applicant: Azena Medical, LLC. Device class: 2.
Summary
Azena Medical's Gemini NOVA 810+980 Soft Tissue Laser is filed under NVK, dental soft tissue lasers. The record doesn't describe the laser beyond its name and that code name.
Class II, 21 CFR 878.4810. The Dental review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Azena Medical filed from Walnut Creek, California. Review took 1 calendar day (March 9 to March 10, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Azena Medical, LLC
- Product code
- Product code NVK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
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