REVOLVE ENVI 600 Advanced Adipose System— 510(k) K193539

Name: FDA 510(k) clearance K193539
Creator: U.S. Food and Drug Administration
Published: 2020-05-28

Substantially Equivalent

Lifecell Corporation

FDA 510(k) clearance K193539 for REVOLVE ENVI 600 Advanced Adipose System, Substantially Equivalent on 2020-05-28. Applicant: Lifecell Corporation. Device class: 2.

Clearance details

Applicant: Lifecell Corporation
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2019-12-20
Decision date: 2020-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.