510(k) Report

Devices descending from K160470

20 later devices reach SculpSure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211681EONDominion Aesthetic Technologies, Inc.20221—
+1K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+1K190743Venus BlissVenus Concept USA, Inc.20194—
+1K171111SculpsureCynosure, Inc.201710—
+2K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+2K222226EONDominion Aesthetic Technologies, Inc.20230—
+2K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+2K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+2K212331BodySculpRohrer Aesthetics, LLC20211—
+2K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+2K192970SlimusHironic Co., Ltd.20200—
+2K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+2K171992SculpSureCynosure, Inc.20178—
+3K233099GladiatorRohrer Aesthetics, LLC20240—
+3K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+3K231971Deka Physiq 360El.En S.P.A.20230—
+3K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+3K182741SculpSureCynosure20195—
+4K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+4K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—