510(k) Report

Devices descending from K070284

172 later devices reach Fralex SR 1500 Laser System (Fralex II SR Laser System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K202172StarWalkerFotona D.O.O.20203—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193426Elite iQCynosure, LLC20201—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K172413MT ONEM&T S.R.L.20175—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K22079410PLTentech Co., Ltd.20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K200786Venus EpileveVenus Concept USA, Inc.20200—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K180406Ellipse YdunEllipse A/S20180—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K242349FoLixLumenis Be, Ltd.20240—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—