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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K212678
Device Name Viveve System, Viveve 2.0 System
Applicant
Viveve Medical, Inc.
345 Inverness Dr. S., Bldg. B, Suite 250
Englewood,  CO  80109
Applicant Contact Kevin Robison
Correspondent
Viveve Medical, Inc.
345 Inverness Dr. S., Bldg. B, Suite 250
Englewood,  CO  80109
Correspondent Contact Kevin Robison
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/24/2021
Decision Date 09/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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