510(k) Report

Devices descending from K070092

128 later devices reach Modification to Velasmooth, Shaper through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+6K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K230167BACK 4Swims America Corp20230—
+6K230037BACK 3Swims America Corp20230—
+6K223110truSculpt iDCutera, Inc.20221—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+6K211107BTL-899 FPBTL Industries, Inc.20213—
+6K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+6K171111SculpsureCynosure, Inc.201710—
+7K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+7K222226EONDominion Aesthetic Technologies, Inc.20230—
+7K213344BTL-899ABTL Industries, Inc.20222—
+7K192970SlimusHironic Co., Ltd.20200—
+7K171992SculpSureCynosure, Inc.20178—
+8K231971Deka Physiq 360El.En S.P.A.20230—
+8K230467BTL-899FBTL Industries, Inc.20231—
+8K182741SculpSureCynosure20195—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—