Cleared Traditional

Gemini NOVA 810+980 Soft Tissue Laser

K260765 · Azena Medical, LLC · Dental

Mar 2026

Decision

Days

Class 2

Risk

About This 510(k) Submission

K260765 is an FDA 510(k) clearance for the Gemini NOVA 810+980 Soft Tissue Laser, a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Azena Medical, LLC (Walnut Creek, US). The FDA issued a Cleared decision on March 10, 2026, 1 days after receiving the submission on March 9, 2026. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K260765 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2026
Decision Date	March 10, 2026
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.