510(k) Report

Devices descending from K991935

1,492 later devices reach Epilight Hair Removal System, Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231215IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008SZhongshan Qizhe Technology Co., Ltd.20230—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K223147myLEDmaskMyblend20234—
+6K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+6K230360IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd.202317—
+6K230021IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd.20236—
+6K230060Light Based Hair Removal Device GP592Shenzhen Gsd Tech Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K222685NIRA Model 2Dermal Photonics Corp20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K221989The OligioWontech Co., Ltd.20222—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K212561MTX-C1Ilooda Co,., Ltd.20220—
+6K221761SoleaConvergent Dental, Inc.202201
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+6K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K221451IPL hair removalShenzhen Lizbella Technology Co.,Ltd20220—
+6K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+6K221083Smartlux MiniMedmix Co., Ltd.20222—
+6K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd.20220—
+6K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+6K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+6K221001IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20226—
+6K213594Echolaser X4Elesta S.P.A20221—
+6K213534PHantom TrilogyResurgeonz, LLC20220—
+6K213830Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited20220—
+6K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+6K213428EdgeProBiolase, Inc.20210—
+6K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K212897IPL Hair Removal Device, model: AI01Shenzhen Century Dongyuan Technology CO, Ltd.20211—
+6K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+6K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+6K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202780SectumNeauvia North America20211—
+6K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+6K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+6K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193266MIINMedico USA, Inc.20210—
+6K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200786Venus EpileveVenus Concept USA, Inc.20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K191086ExciplexClarteis20194—
+6K192430Epic 980Biolase, Inc.20195—
+6K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K183450EmBody SystemInmode MD, Ltd.20198—
+6K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K183566CLARITY II Laser SystemLutronic Corporation201911
+6K183247dpl FacewareLed Technologies, Inc.201910—
+6K182173Joule SystemSciton, Inc20195—
+6K183118dpl SpotLiteLed Technologies, Inc.201922—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+6K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K180875Poly RejuvMedtek Skincare, LLC20180—
+6K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+6K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+6K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+6K1718212 Face / Face EvolutionHeat IN A Click201858—