Cleared Traditional

Gemini 2 810+980 Soft Tissue Laser

K210350 · Azena Medical, LLC · Dental

Nov 2021

Decision

283d

Days

Class 2

Risk

About This 510(k) Submission

K210350 is an FDA 510(k) clearance for the Gemini 2 810+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 November 18, 2021, 283 days after receiving the submission on February 8, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K210350 FDA.gov
FDA Decision	Cleared 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

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.