510(k) Report

Devices descending from K022060

376 later devices reach Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K223727LavieenWontech Co., Ltd.20234—
+5K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K221873NeoGen PSR SystemEnergist Limited20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K213674CellFX SystemPulse Biosciences, Inc.20220—
+5K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+5K221761SoleaConvergent Dental, Inc.202201
+5K222075CellFX SystemPulse Biosciences, Inc.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221671CellFX® SystemPulse Biosciences, Inc.20220—
+5K210084SilkroHironic Co., Ltd.20223—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212107ReversoIntelis Instruments, Ltd.20211—
+5K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K171227StarWalkerFotona D.O.O.20177—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152714Quanta ForteQuanta System Spa201513—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+6K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K241406LavieenWontech Co., Ltd.20242—
+6K233123SilkroHironic Co., Ltd.20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233147PiXel8-RFRohrer Aesthetics20230—
+6K232236EchoQuanta System Spa20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K211000AcutronIlooda Co,., Ltd.20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K201685PotenzaJeisys Medical, Inc.20219—
+6K201735PlaDuo SystemShenB Co., Ltd.20203—
+6K202172StarWalkerFotona D.O.O.20203—
+6K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+6K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193426Elite iQCynosure, LLC20201—