510(k) Report

Devices descending from K003538

447 later devices reach TDP CQ-27 Heat Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K172413MT ONEM&T S.R.L.20175—
+7K171227StarWalkerFotona D.O.O.20177—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+7K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+7K171111SculpsureCynosure, Inc.201710—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+7K161981Olive PlusAma Network, Inc.20160—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—
+7K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+8K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+8K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+8K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+8K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K22079410PLTentech Co., Ltd.20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+8K213344BTL-899ABTL Industries, Inc.20222—
+8K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K192970SlimusHironic Co., Ltd.20200—
+8K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+8K202172StarWalkerFotona D.O.O.20203—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K182604New EraStep UP Skin Laser, LLC201801
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K171992SculpSureCynosure, Inc.20178—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—