510(k) Report

Devices descending from K001746

714 later devices reach Lightsheer Pulsed Diode Array Laser System (Family of Products) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc.201496—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+7K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+7K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2…Shenzhen Semlamp Intelligent Technology Co., Ltd.20260—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K253304IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)Dongguan Lide Electric Appliance Co., Ltd.20250—
+7K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+7K252209IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)Foshan Jindi Electric Appliance Co., Ltd.20251—
+7K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K251176IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20251—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251984Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250194Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)Shenzhen Ulike Smart Electronics Co., Ltd.20252—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)Shenzhen Ulike Smart Electronics Co., Ltd.202413—
+7K242197IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)Shenzhen Huaruibo Electric Appliances Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241834IPL Hair Removal Device (BE932C, BE932D, BE932E)Shenzhen Yang WO Electronic Co., Ltd.20242—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K241205Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S…Shenzhen Ulike Smart Electronics Co., Ltd.20242—
+7K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd.20249—
+7K241343IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A…Shenzhen Lescolton Electrical Appliance Co., Ltd.20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240583IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W…Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K241106Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20242—
+7K240093IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd.20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+7K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+7K232124IPL Hair Removal, Model: W-1095, W-1098Shenzhen Wochuan Electronic Co., Ltd.20230—
+7K231800IPL Hair Removal Device, Model (s): JP1, JR3, JR8, JR9Shenzhen Qianyu Technology Co., Ltd.20231—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K231215IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008SZhongshan Qizhe Technology Co., Ltd.20230—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+7K230360IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd.202317—
+7K230021IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd.20236—
+7K230060Light Based Hair Removal Device GP592Shenzhen Gsd Tech Co., Ltd.20230—
+7K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited202211—
+7K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221451IPL hair removalShenzhen Lizbella Technology Co.,Ltd20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd.20220—
+7K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K221001IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20226—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K213830Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited20220—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+7K212897IPL Hair Removal Device, model: AI01Shenzhen Century Dongyuan Technology CO, Ltd.20211—
+7K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+7K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+7K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+7K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+7K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—