510(k) Report

Devices descending from K034030

252 later devices reach Apogee Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K201773PicohiHironic Co., Ltd.20215—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K202172StarWalkerFotona D.O.O.20203—
+4K200616E>EyeCE-Swin20200—
+4K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+4K173700PICOPLUS Laser SystemLutronic Corporation20187—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173199PicoSure WorkstationCynosure, Inc.20189—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163222Discovery Pico FamilyQuanta System Spa201630—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+4K141555AdvantageLutronic Corporation201414—
+4K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+5K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+5K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K241656Eneka SelectifTermosalud20241—
+5K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+5K240752Deka ToroEl.En S.P.A.20240—
+5K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+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—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K210226PicoSure WorkstationCynosure, LLC20213—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183452Vbeam Prima Laser SystemCandela Corp.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—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+5K172413MT ONEM&T S.R.L.20175—
+5K171227StarWalkerFotona D.O.O.20177—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+5K162886Deka Motus AXEl.En Electronic Engineering Spa20171—