510(k) Report

Devices descending from K033461

316 later devices reach Candela Vbeam Pulse Dye Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212127PicocaremajestyWontech Co., Ltd.20226—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201773PicohiHironic Co., Ltd.20215—
+6K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K172413MT ONEM&T S.R.L.20175—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+7K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+7K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+7K22079410PLTentech Co., Ltd.20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K210084SilkroHironic Co., Ltd.20223—
+7K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K153229SuperbiumBios S.R.L.20162—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K233123SilkroHironic Co., Ltd.20241—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K230077LaserMENeauvia North America20232—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K193426Elite iQCynosure, LLC20201—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+10K223871Miria Skin Treatment SystemAVAVA, Inc.20232—