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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Dental, Soft Tissue
510(k) Number K260765
Device Name Gemini NOVA 810+980 Soft Tissue Laser
Applicant
Azena Medical, LLC
1777 Botelho Dr.
Suite 100
Walnut Creek,  CA  94596
Applicant Contact Lindsay Tilton
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact DAVE YUNGVIRT
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Codes
GEX   ILY  
Date Received03/09/2026
Decision Date 03/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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