510(k) Report

Devices descending from K960475

403 later devices reach Modified Luxar LX-20 Family CO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K202172StarWalkerFotona D.O.O.20203—
+8K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K172413MT ONEM&T S.R.L.20175—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+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—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K22079410PLTentech Co., Ltd.20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K212472AgeJetTriworks Group Srl20220—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K200616E>EyeCE-Swin20200—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+10K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+10K253803MILAN SystemLumenis Be, 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—
+10K253750BTL-785NEHBTL Industries, Inc.20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+10K251254Ignite RF SystemInMode, Ltd.20260—
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K242532BTL-785BNF-EBTL Industries, Inc.20241—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+11K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—