510(k) Report

Devices descending from K030846

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232236EchoQuanta System Spa20230—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202172StarWalkerFotona D.O.O.20203—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K172413MT ONEM&T S.R.L.20175—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K22079410PLTentech Co., Ltd.20220—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K212472AgeJetTriworks Group Srl20220—