510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260765Substantially Equivalent

Gemini NOVA 810+980 Soft Tissue Laser

Azena Medical, Walnut Creek CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260765 is the FDA 510(k) clearance record for Gemini NOVA 810+980 Soft Tissue Laser, a class II device, cleared for Azena Medical, LLC on under FDA product code NVK (Laser, Dental, Soft Tissue). FDA's definition for product code NVK reads: "Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry". FDA records list 4 510(k) clearances for Azena Medical, LLC, from to . As of , FDA records show no recalls naming K260765.

Clearance record

Decision date
Received
(1 day to decision)
Product code
NVK Laser, Dental, Soft Tissue
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Azena Medical, LLC 1777 Botelho Dr., Walnut Creek CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code NVK

Trailing 12 months
2 clearances under product code NVK in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NVK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260