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510(k) K193539

REVOLVE ENVI 600 Advanced Adipose System by Lifecell Corporation — Product Code MUU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2020
Date Received
December 20, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

Other clearances by Lifecell Corporation

  • K163647 — Revolve Envi 600 Advanced Adipose System (August 25, 2017)
  • K162752 — ARTIA Reconstructive Tissue Matrix Perforated (February 24, 2017)
  • K150712 — LTM-Perforated Surgical Mesh (July 2, 2015)
  • K142326 — HP Tissue Matrix (December 23, 2014)

Other clearances for product code MUU

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  • K203800 — SyntrFuge System (July 2, 2021)
  • K202443 — Smart Kit Basic, Smart Kit Pro (March 11, 2021)
  • K193363 — Dermapose Refresh (April 14, 2020)
  • K182732 — JTL-250-01 (November 18, 2019)
  • K191564 — Progenikine Concentrating System 25 mL System (November 7, 2019)
  • K190386 — KTA Adipose Treatment Kit (October 10, 2019)
  • K190278 — AuraGen 123 Suction Lipoplasty System (A123) (May 3, 2019)
  • K172717 — Automatic Tissue Processing Unit (May 25, 2018)
  • K172714 — LipiVage (December 8, 2017)