510(k) Report

Devices descending from K191068

6 later devices reach Powersculp laser lipolysis system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+1K212331BodySculpRohrer Aesthetics, LLC20211—
+1K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+1K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+2K233099GladiatorRohrer Aesthetics, LLC20240—
+2K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—