510(k) Report

Devices descending from K042165

241 later devices reach Cutera Tabletop Aesthetic Product through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K241656Eneka SelectifTermosalud20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K232236EchoQuanta System Spa20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K200693K2 MobileHulaser, Inc.20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+5K192856MT OneM&T S.R.L.20202—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193486Epic 980Biolase, Inc.20202—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+5K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K180044SIROLaser BlueDentsply Sirona201812—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K172413MT ONEM&T S.R.L.20175—
+5K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+5K161981Olive PlusAma Network, Inc.20160—
+5K160470SculpSureCynosure, Inc.201620—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+5K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+6K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+6K234085LUNE™ PureHygieneEnamel Pure20241—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K22079410PLTentech Co., Ltd.20220—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+6K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+6K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+6K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+6K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+6K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+6K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+6K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+6K182604New EraStep UP Skin Laser, LLC201801
+6K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+6K171111SculpsureCynosure, Inc.201710—
+7K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—