510(k) Report

Devices descending from K072564

266 later devices reach Alma Lasers Harmony XL Multi-Application Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K193266MIINMedico USA, Inc.20210—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201406PicowonWontech Co., Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200736Stardust MedI.T.S. Group S.R.L.20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K173199PicoSure WorkstationCynosure, Inc.20189—
+4K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+4K171227StarWalkerFotona D.O.O.20177—
+4K162755PicocareWontech Co., Ltd.20179—
+4K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+4K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+4K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+4K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+4K152856Helios IIILaseroptek Co., Ltd.20165—
+4K160480PicoSure WorkstationCynosure, Inc.201620—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+4K152611V20 systemViora, Ltd.20164—
+4K150035V10 systemViora, Ltd.201531—
+4K150326PicoWay Laser SystemCandela Corporation201568—
+4K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+4K143105Picosure WorkstationCynosure, Inc.201549—
+4K142372Pico Way Laser SystemCandela Corpation201470—
+4K140719Picosure WorkstationCynosure, Inc.201450—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+5K241656Eneka SelectifTermosalud20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+5K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+5K232236EchoQuanta System Spa20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K212663Helios IV 785Laseroptek Co., Ltd.20223—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+5K210226PicoSure WorkstationCynosure, LLC20213—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K202172StarWalkerFotona D.O.O.20203—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193426Elite iQCynosure, LLC20201—
+5K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+5K191685PicoWay Laser SystemCandela Corporation201920—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+5K182997enlighten III Laser SystemCutera, Inc.20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+5K181272Picocare FamilyWontech Co., Ltd.20188—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+5K160368EVO platformQuanta System Spa201636—
+5K152012EVO platformQuanta System Spa201537—
+5K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K261570Picosure WorkstationCynosure, LLC20260—
+6K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+6K252369Boston Pico755Boston Aesthetics, Inc.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K243957PicoalexWontech Co., Ltd.20250—