Cleared Traditional

K260765 - Gemini NOVA 810+980 Soft Tissue Laser (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260765 · Azena Medical, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
1d
Days
Class 2
Risk

K260765 is an FDA 510(k) clearance for the Gemini NOVA 810+980 Soft Tissue Laser. Classified as Laser, Dental, Soft Tissue (product code NVK), Class II - Special Controls.

Submitted by Azena Medical, LLC (Walnut Creek, US). The FDA issued a Cleared decision on March 10, 2026 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4810 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Azena Medical, LLC devices

Submission Details

510(k) Number K260765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code NVK Laser, Dental, Soft Tissue
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NVK Laser, Dental, Soft Tissue

All 15
Devices cleared under the same product code (NVK) and FDA review panel - the closest regulatory comparables to K260765.
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