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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 K201687
Device Name Avenda Health Treatment System
Applicant
Avenda Health, Inc.
929 Colorado Ave.
Santa Monica,  CA  90401
Applicant Contact Brittany Berry-Pusey
Correspondent
Experien Group, LLC
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Michael J Billig
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
FRN   LLZ  
Date Received06/22/2020
Decision Date 11/30/2020
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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