510(k) Report

Devices descending from K071872

127 later devices reach Velashape through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243929Oligio XWontech Co., Ltd.20250—
+5K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+5K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K230167BACK 4Swims America Corp20230—
+5K230037BACK 3Swims America Corp20230—
+5K223110truSculpt iDCutera, Inc.20221—
+5K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+5K211681EONDominion Aesthetic Technologies, Inc.20221—
+5K212331BodySculpRohrer Aesthetics, LLC20211—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+5K211107BTL-899 FPBTL Industries, Inc.20213—
+5K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+5K171111SculpsureCynosure, Inc.201710—
+6K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K222226EONDominion Aesthetic Technologies, Inc.20230—
+6K213344BTL-899ABTL Industries, Inc.20222—
+6K192970SlimusHironic Co., Ltd.20200—
+6K171992SculpSureCynosure, Inc.20178—
+7K231971Deka Physiq 360El.En S.P.A.20230—
+7K230467BTL-899FBTL Industries, Inc.20231—
+7K182741SculpSureCynosure20195—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—