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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 K210350
Device Name Gemini 2 810+980 Soft Tissue Laser
Applicant
Azena Medical, LLC
3021 Citrus Circle Suite 180
Walnut Creek,  CA  94598
Applicant Contact Lindsay Tilton
Correspondent
Azena Medical, LLC
3021 Citrus Circle Suite 180
Walnut Creek,  CA  94598
Correspondent Contact Lindsay Tilton
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Codes
GEX   ILY  
Date Received02/08/2021
Decision Date 11/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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