510(k) Report

Devices descending from K151179

26 later devices reach ZELTIQ CoolSculpting System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160470SculpSureCynosure, Inc.201620—
+1K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+2K211681EONDominion Aesthetic Technologies, Inc.20221—
+2K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+2K190743Venus BlissVenus Concept USA, Inc.20194—
+2K171111SculpsureCynosure, Inc.201710—
+2K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+3K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+3K222226EONDominion Aesthetic Technologies, Inc.20230—
+3K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+3K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+3K212331BodySculpRohrer Aesthetics, LLC20211—
+3K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+3K192970SlimusHironic Co., Ltd.20200—
+3K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+3K171992SculpSureCynosure, Inc.20178—
+3K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+4K233099GladiatorRohrer Aesthetics, LLC20240—
+4K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+4K231971Deka Physiq 360El.En S.P.A.20230—
+4K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+4K182741SculpSureCynosure20195—
+4K172144CoolSculpting SystemZeltiq Aesthetics20177—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+5K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805