510(k) Report

Devices descending from K171069

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172144CoolSculpting SystemZeltiq Aesthetics20177—
+2K182741SculpSureCynosure20195—
+2K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+3K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+3K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+3K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+4K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+4K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—