510(k) Report

Devices descending from K061603

48 later devices reach Smoothshapes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+1K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+1K083629SmoothshapesEleme Medical, Inc.200927—
+2K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+2K111501I-Lipo SystemChromogenex Technologies Limited201215—
+2K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+3K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+3K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+3K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K213534PHantom TrilogyResurgeonz, LLC20220—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K192275invisa-RED ELITEIR Technology, LLC20201—
+4K170709CURVE Laser SystemYolo Medical, Inc.20170—
+4K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+4K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+4K150724SculpSureCynosure, Inc.201521—
+4K150230SculpSureCynosure, Inc.201521—
+4K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—
+5K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+5K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+5K160470SculpSureCynosure, Inc.201620—
+6K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+6K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K171111SculpsureCynosure, Inc.201710—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+7K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+7K222226EONDominion Aesthetic Technologies, Inc.20230—
+7K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+7K192970SlimusHironic Co., Ltd.20200—
+7K171992SculpSureCynosure, Inc.20178—
+8K231971Deka Physiq 360El.En S.P.A.20230—
+8K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+8K182741SculpSureCynosure20195—
+9K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+9K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—