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510(k) K260765

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2026
Date Received
March 9, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

Other clearances by Azena Medical, LLC

  • K210350 — Gemini 2 810+980 Soft Tissue Laser (November 18, 2021)
  • K192617 — Gemini 810+980 Soft Tissue Laser (February 20, 2020)
  • K152032 — ELUMI 810 + 980 Soft Tissue Laser (September 16, 2015)

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