510(k) Report

Devices descending from K020958

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K180406Ellipse YdunEllipse A/S20180—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K171227StarWalkerFotona D.O.O.20177—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K152714Quanta ForteQuanta System Spa201513—
+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—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K244060eCO2 3DLutronic Corporation20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K232236EchoQuanta System Spa20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K172413MT ONEM&T S.R.L.20175—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+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—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K22079410PLTentech Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+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—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+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—