510(k) Report

Devices descending from K100230

26 later devices reach Smoothshapes System, 11318-120V, 11319-230V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+2K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+2K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+2K150724SculpSureCynosure, Inc.201521—
+2K150230SculpSureCynosure, Inc.201521—
+3K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+3K160470SculpSureCynosure, Inc.201620—
+4K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+4K211681EONDominion Aesthetic Technologies, Inc.20221—
+4K212331BodySculpRohrer Aesthetics, LLC20211—
+4K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+4K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+4K190743Venus BlissVenus Concept USA, Inc.20194—
+4K171111SculpsureCynosure, Inc.201710—
+5K233099GladiatorRohrer Aesthetics, LLC20240—
+5K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+5K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+5K222226EONDominion Aesthetic Technologies, Inc.20230—
+5K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+5K192970SlimusHironic Co., Ltd.20200—
+5K171992SculpSureCynosure, Inc.20178—
+6K231971Deka Physiq 360El.En S.P.A.20230—
+6K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K182741SculpSureCynosure20195—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—