510(k) Report

Devices descending from K182741

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

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