510(k) Report

Devices descending from K994014

1,283 later devices reach Esc Intense Pulsed Light Systems: Epilight and Multilight through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241102Luna 4 plusForeo, Inc.20245—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+6K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+6K240248Volnewmer™Classys, Inc.20241—
+6K233849BTL-499BTL Industries, Inc.20240—
+6K233604BTL-785SBTL Industries, Inc.20243—
+6K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+6K23299210THERMATentech, Inc.20230—
+6K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+6K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+6K231146AliTightAlic Iotech, LLC20230—
+6K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+6K230663DensityJeisys Medical, Inc.20232—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+6K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+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—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K222685NIRA Model 2Dermal Photonics Corp20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+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—
+6K222369PURE LaserEndymed Medical, 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—
+6K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+6K221083Smartlux MiniMedmix Co., Ltd.20222—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+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—
+6K213594Echolaser X4Elesta S.P.A20221—
+6K213534PHantom TrilogyResurgeonz, LLC20220—
+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—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+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—
+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—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+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—
+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