510(k) Report

Devices descending from K053611

95 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—
+1K083629SmoothshapesEleme Medical, Inc.200927—
+1K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+1K061603SmoothshapesBiocellulase, Inc.200648—
+2K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+2K160075Accent XLAlma Lasers, Inc.20160—
+2K120510TranscendSyneron Medical, Ltd.201318—
+2K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+2K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+2K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+2K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+2K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K163415SlimShape SystemSyneron Medical, Ltd.201714—
+3K162512truSculptCutera, Inc.20165—
+3K143559XP1000 RFBTL Industries, Inc.20157—
+3K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K111501I-Lipo SystemChromogenex Technologies Limited201215—
+3K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+4K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K23299210THERMATentech, Inc.20230—
+4K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221989The OligioWontech Co., Ltd.20222—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K192224BTL-899Btl20198—
+4K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+4K172004truSculptCutera, Inc.20173—
+4K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+4K152731XP1100 RFBTL Industries, 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—
+4K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+4K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+5K253504Volnewmer™Classys, Inc.20260—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K250200InbellaBody SystemInbella Medical, Inc.20250—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K221407truSculpt iDCutera, Inc.20222—
+5K213534PHantom TrilogyResurgeonz, LLC20220—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K202199BTL-899STBtl20216—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+5K170709CURVE Laser SystemYolo Medical, Inc.20170—
+5K160470SculpSureCynosure, Inc.201620—
+5K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+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—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K171111SculpsureCynosure, Inc.201710—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+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—
+7K213344BTL-899ABTL Industries, Inc.20222—
+7K192970SlimusHironic Co., Ltd.20200—
+7K171992SculpSureCynosure, Inc.20178—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K231971Deka Physiq 360El.En S.P.A.20230—
+8K230467BTL-899FBTL Industries, Inc.20231—
+8K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+8K182741SculpSureCynosure20195—
+9K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—