510(k) Report

Devices descending from K022884

642 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K140120EPIC 10Biolase, Inc.20141—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+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—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K244060eCO2 3DLutronic Corporation20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K243488Vmat ProTermosalud20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K232236EchoQuanta System Spa20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K223727LavieenWontech Co., Ltd.20234—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230077LaserMENeauvia North America20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—