510(k) Report

Devices descending from K024093

756 later devices reach Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242349FoLixLumenis Be, Ltd.20240—
+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—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+6K232236EchoQuanta System Spa20230—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+6K221083Smartlux MiniMedmix Co., Ltd.20222—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+6K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+6K202172StarWalkerFotona D.O.O.20203—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193426Elite iQCynosure, LLC20201—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K181868SHINY RPL SystemIds, Ltd.20181—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K180875Poly RejuvMedtek Skincare, LLC20180—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K1718212 Face / Face EvolutionHeat IN A Click201858—
+6K180406Ellipse YdunEllipse A/S20180—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170068Softcure 96Wellray Medical Laser, Inc.20170—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K152012EVO platformQuanta System Spa201537—
+6K151629Guardian 1000Quanta System Spa20150—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150051ExiliteBTL Industries, Inc.20150—