LipiVage

FDA 510(k) K172714 · Genesis Biosystems, Inc.

Substantially Equivalent

510(k) numberK172714

Submission

Device name
LipiVage
Applicant
Genesis Biosystems, Inc.
Lewisville, TX, US
Received
September 8, 2017
Decision date
December 8, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUU – System, Suction, Lipoplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5040
Specialty
General, Plastic Surgery

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).

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K203800SyntrFuge SystemMUU · Traditional Syntr Health Technologies, Inc.07/02/2021SE
K202443Smart Kit Basic, Smart Kit ProMUU · Traditional Bsl Co., Ltd.03/11/2021SE
K193539REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional Lifecell Corporation05/28/2020SE
K193363Dermapose RefreshMUU · Traditional Puregraft, LLC04/14/2020SE
K182732JTL-250-01MUU · Traditional Jointechlabs, Inc.11/18/2019SE
K191564Progenikine Concentrating System 25 mL SystemMUU · Traditional Emcyte Corporation11/07/2019SE
K190386KTA Adipose Treatment KitMUU · Traditional Stemics S.A.S10/10/2019SE
K190278AuraGen 123 Suction Lipoplasty System (A123)MUU · Traditional Auragen Aesthetics, LLC05/03/2019SE
K172717Automatic Tissue Processing UnitMUU · Traditional Bsl Co.05/25/2018SE

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Questions and answers

When was LipiVage cleared by the FDA?

LipiVage (K172714) received a 510(k) decision of Substantially Equivalent on December 8, 2017, 91 days after the submission was received.

What is the product code of K172714?

The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.