510(k) Report

Devices descending from K022569

1,121 later devices reach Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular Lesions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+5K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K250852CoolfaseAsterasys Co., Ltd.20250—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251327XERFLutronic Corporation202501
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+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—
+6K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K242241SunnyShenB Co., Ltd.20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243488Vmat ProTermosalud20250—
+6K240311JETT Medical IICompex, Spol, S.R.O.20250—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K242688Finiff SystemSkingrab Co., Ltd.20240—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241656Eneka SelectifTermosalud20241—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+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—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240248Volnewmer™Classys, Inc.20241—
+6K233849BTL-499BTL Industries, Inc.20240—
+6K233604BTL-785SBTL Industries, Inc.20243—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+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—
+6K231146AliTightAlic Iotech, LLC20230—
+6K230663DensityJeisys Medical, Inc.20232—
+6K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230077LaserMENeauvia North America20232—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K221989The OligioWontech Co., Ltd.20222—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K221761SoleaConvergent Dental, Inc.202201
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K213594Echolaser X4Elesta S.P.A20221—
+6K213428EdgeProBiolase, Inc.20210—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193266MIINMedico USA, Inc.20210—
+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—