510(k) Report

Devices descending from K101506

156 later devices reach LUX1540, LUX1440 & LUX2940 Laser Handpieces through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K241656Eneka SelectifTermosalud20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232236EchoQuanta System Spa20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K22079410PLTentech Co., Ltd.20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+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—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K172413MT ONEM&T S.R.L.20175—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+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—
+6K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)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—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242349FoLixLumenis Be, Ltd.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+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—
+7K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—