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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K192617
Device Name Gemini 810+980 Soft Tissue Laser
Applicant
Azena Medical, LLC
3021 Citrus Cir. Suite 180
Walnut Creek,  CA  94598
Applicant Contact Lindsay Tilton
Correspondent
Azena Medical, LLC
3021 Citrus Cir. Suite 180
Walnut Creek,  CA  94598
Correspondent Contact Lindsay Tilton
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ILY  
Date Received09/23/2019
Decision Date 02/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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