Cleared Traditional

Gemini 2 810+980 Soft Tissue Laser (K210350) - FDA 510(k) Clearance

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

K210350 · Azena Medical, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
283d
Days
Class 2
Risk

K210350 is an FDA 510(k) clearance for the Gemini 2 810+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 November 18, 2021 after a review of 283 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Azena Medical, LLC devices

Submission Details

510(k) Number K210350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date November 18, 2021
Days to Decision 283 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 127d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - NVK Laser, Dental, Soft Tissue

All 15
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