FDA.reportPublic FDA data

510(k) K244050

Device
AYON Body Contouring System (AYON SYSTEM)
Applicant
Apyx Medical Corporation
510(k) number
K244050
Product code
QPB
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-12
Date received
2024-12-31
Regulation
878.5040
Classification name
System, Suction, Lipoplasty For Removal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Angela Huber
Address
5115 Ulmerton Rd. Clearwater FL US 33760 33760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QPB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical Corporation2026-05-08
K252495LSSA (NP-200)Newpong Co., Ltd.2026-04-03
K244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLC2025-04-25
K242804PAL Aspiration SystemMicroaire Surgical Instruments, LLC2024-12-30
K241835AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx2024-11-27
K240188Vitruvian LiposaberBlack & Black Surgical, Inc.2024-09-13
K212969LiposaverLhbiomed Co., Ltd.2024-08-07
K220318PAL Infiltration SystemMicroaire Surgical Instruments, LLC2022-10-14
K212024PAL SystemMicroaire Surgical Instruments, LLC2022-06-10
K192694PAL Single-Use CannulasMicroaire Surgical Instruments2020-05-14
K200168Dermapose AccessPuregraft, LLC2020-04-22
K190555PowerX Lipo SystemSolta Medical2019-05-01
K190551VASERlipo SystemSolta Medical2019-05-01
K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC2017-10-13
K170629VITRUVIAN INFILTRATION PUMPBlack & Black Surgical, Inc.2017-06-22