510(k) Report

Devices descending from K021180

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K183156V-LaserWontech Co., Ltd.20193—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K172413MT ONEM&T S.R.L.20175—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+6K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+6K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+6K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+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—
+7K244060eCO2 3DLutronic Corporation20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+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—
+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—
+7K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+7K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K210084SilkroHironic Co., Ltd.20223—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K153229SuperbiumBios S.R.L.20162—
+8K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+8K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+8K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241270BTL-754BTL Industries, Inc.20251—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K230077LaserMENeauvia North America20232—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+9K193426Elite iQCynosure, LLC20201—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+9K163196ACTION II Laser SystemLutronic Corporation20170—
+9K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+9K142860Lumenis M22 SystemLumenis, Ltd.2015381
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+10K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+10K202503ChromeQuanta System Spa202012—
+10K200786Venus EpileveVenus Concept USA, Inc.20200—
+10K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+10K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+10K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+10K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+10K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+10K153566Magma SystemFormatk Systems, Ltd.20162—
+11K253765Vanish ProDdc Technologies, Inc.20260—
+11K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—