510(k) Report

Devices descending from K002421

744 later devices reach Candela Mid IR Diode Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K160368EVO platformQuanta System Spa201636—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K150035V10 systemViora, Ltd.201531—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K140120EPIC 10Biolase, Inc.20141—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K124064Young AgainEspansione Marketing S.P.A20131—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K113588Spectra Laser SystemLutronic Corporation201282—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+8K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+8K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+8K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K244060eCO2 3DLutronic Corporation20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K223727LavieenWontech Co., Ltd.20234—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230077LaserMENeauvia North America20232—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K222685NIRA Model 2Dermal Photonics Corp20230—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K193266MIINMedico USA, Inc.20210—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K193426Elite iQCynosure, LLC20201—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K191086ExciplexClarteis20194—
+8K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+8K173199PicoSure WorkstationCynosure, Inc.20189—