The Lipogems System

Q: What is the product code of K142682?

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

FDA 510(k) K142682 · Lipogems International Spa

Substantially Equivalent

510(k) numberK142682

Submission

Device name: The Lipogems System
Applicant: Lipogems International Spa
Milano, IT
Received: September 19, 2014
Decision date: December 22, 2014
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).

Other 510(k)s with product code MUU

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K203800	SyntrFuge SystemMUU · Traditional	Syntr Health Technologies, Inc.	07/02/2021SE
K202443	Smart Kit Basic, Smart Kit ProMUU · Traditional	Bsl Co., Ltd.	03/11/2021SE
K193539	REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional	Lifecell Corporation	05/28/2020SE
K193363	Dermapose RefreshMUU · Traditional	Puregraft, LLC	04/14/2020SE
K182732	JTL-250-01MUU · Traditional	Jointechlabs, Inc.	11/18/2019SE
K191564	Progenikine Concentrating System 25 mL SystemMUU · Traditional	Emcyte Corporation	11/07/2019SE
K190386	KTA Adipose Treatment KitMUU · Traditional	Stemics S.A.S	10/10/2019SE
K190278	AuraGen 123 Suction Lipoplasty System (A123)MUU · Traditional	Auragen Aesthetics, LLC	05/03/2019SE
K172717	Automatic Tissue Processing UnitMUU · Traditional	Bsl Co.	05/25/2018SE

More from Bsl Co.

510(k)	Device	Decision
K171135	Lipogems SystemMUU · Traditional	05/18/2017SE
K161636	Lipogems SystemMUU · Traditional	11/04/2016SE

Questions and answers

When was The Lipogems System cleared by the FDA?

The Lipogems System (K142682) received a 510(k) decision of Substantially Equivalent on December 22, 2014, 94 days after the submission was received.

What is the product code of K142682?

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