510(k) Report

Devices descending from K981922

22 later devices reach Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC20172—
+1K053451Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252…Moeller Medical GmbH & Co. KG200613—
+1K010311Lipomatic; Lipomatic Liposuction DeviceEuromi S.A20011—
+1K992855XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc.20002—
+2K254135LipoSurg ARTISTNouvag AG20260—
+2K261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsApyx Medical Corporation20260—
+2K241835AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx20240—
+2K212024PAL SystemMicroaire Surgical Instruments, LLC20223—
+2K192694PAL Single-Use CannulasMicroaire Surgical Instruments20200—
+2K082025Body-JetHuman Med AG200801
+2K072793Liposat Basic (Infiltration Pump), Model 92-007 688Moeller Medical GmbH & Co. KG20082—
+2K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG20074—
+2K021813Hydrocision General Surgery Fluidjet SystemHydrocision, Inc.20030—
+2K010666XPS 3000 System with Reciprocating Adapter and Suction CannulaeMedtronic Xomed, Inc.20010—
+3K251944Lipocosm Harmonic SystemLipocosm, LLC20260—
+3K253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical Corporation20260—
+3K240188Vitruvian LiposaberBlack & Black Surgical, Inc.20240—
+3K170629Vitruvian Infiltration PumpBlack & Black Surgical, Inc.20171—
+3K150134Basic, Dominant Flex, KV-6Medela AG20152—
+4K220318PAL Infiltration SystemMicroaire Surgical Instruments, LLC20220—
+4K160950MiniscavSedation Systems, LLC201701
+4K170329Basic, Dominant FlexModela AG201701