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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty
510(k) Number K193539
Device Name REVOLVE ENVI 600 Advanced Adipose System
Applicant
Lifecell Corporation
One Millennium Way
Branchburg,  NJ  08876
Applicant Contact Bozhana Hegarty
Correspondent
Lifecell Corporation
One Millennium Way
Branchburg,  NJ  08876
Correspondent Contact Bozhana Hegarty
Regulation Number878.5040
Classification Product Code
MUU  
Date Received12/20/2019
Decision Date 05/28/2020
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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