510(k) Report

Devices descending from K964074

307 later devices reach Diolite 532 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc.202402
+5K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+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—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+5K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+5K212663Helios IV 785Laseroptek Co., Ltd.20223—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K212241Quatera 700Carl Zeiss Meditec, AG20221—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K210226PicoSure WorkstationCynosure, LLC20213—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+5K191685PicoWay Laser SystemCandela Corporation201920—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182997enlighten III Laser SystemCutera, Inc.20180—
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181272Picocare FamilyWontech Co., Ltd.20188—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+5K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+5K161185LUCERNA Dental LaserViax Dental Lab20160—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K160368EVO platformQuanta System Spa201636—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152012EVO platformQuanta System Spa201537—
+5K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+5K141065Constellation Vision SystemAlcon Research, Ltd.201426
+5K131839DC 7Dc International, LLC20130—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+5K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K261570Picosure WorkstationCynosure, LLC20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+6K252369Boston Pico755Boston Aesthetics, Inc.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K250501System SophiThis AG20250—
+6K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology 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—
+6K243957PicoalexWontech Co., Ltd.20250—
+6K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K232236EchoQuanta System Spa20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K230858Quatera 700Carl Zeiss Meditec, AG20230—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—