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510(k) K210350

Gemini 2 810+980 Soft Tissue Laser by Azena Medical, LLC — Product Code NVK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2021
Date Received
February 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Dental, Soft Tissue
Device Class
Class II
Regulation Number
878.4810
Review Panel
DE
Submission Type

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

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  • K152032 — ELUMI 810 + 980 Soft Tissue Laser (September 16, 2015)

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