Vitruvian Liposaber

FDA 510(k) K240188 · Black & Black Surgical, Inc.

Substantially Equivalent

510(k) numberK240188

Submission

Device name
Vitruvian Liposaber
Applicant
Black & Black Surgical, Inc.
Tucker, GA, US
Received
January 24, 2024
Decision date
September 13, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

Other 510(k)s with product code QPB

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K254135LipoSurg ARTISTQPB · Traditional Nouvag AG09/05/2026SE
K261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsQPB · Traditional Apyx Medical Corporation08/21/2026SE
K251944Lipocosm Harmonic SystemQPB · Traditional Lipocosm, LLC06/08/2026SE
K253396AYON Body Contouring System™ (AYON SYSTEM)QPB · Traditional Apyx Medical Corporation05/08/2026SE
K252495Lssa (NP-200)QPB · Traditional Newpong Co., Ltd.04/03/2026SE
K244050AYON Body Contouring System (AYON SYSTEM)QPB · Traditional Apyx Medical Corporation05/12/2025SE
K244026PAL 7020 ConsoleQPB · Traditional Microaire Surgical Instruments, LLC04/25/2025SE
K242804PAL Aspiration SystemQPB · Traditional Microaire Surgical Instruments, LLC12/30/2024SE
K241835AirSculpt Body Contouring System (AIRS-1-SYS)QPB · Traditional Cellmyx11/27/2024SE
K212969LiposaverQPB · Traditional Lhbiomed Co., Ltd.08/07/2024SE

More from Lhbiomed Co., Ltd.

510(k)DeviceDecision
K170629Vitruvian Infiltration PumpQPB · Traditional 06/22/2017SE
K161722Vitruvian Ultimate AspiratorQPB · Traditional 07/26/2016SE
K072124Black and Black Electrosurgical Cutting and Coagulation Forceps and ElectrodesGEI · Traditional 01/18/2008SE

Questions and answers

When was Vitruvian Liposaber cleared by the FDA?

Vitruvian Liposaber (K240188) received a 510(k) decision of Substantially Equivalent on September 13, 2024, 233 days after the submission was received.

What is the product code of K240188?

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