510(k) Report

Devices descending from K034030

252 later devices reach Apogee Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+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—
+6K261570Picosure WorkstationCynosure, LLC20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252369Boston Pico755Boston Aesthetics, Inc.20260—
+6K252877SANDRO DualWontech Co., Ltd.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—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K243957PicoalexWontech Co., Ltd.20250—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242349FoLixLumenis Be, Ltd.20240—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K213889PicoStarAsclepion Laser Technologies GmbH20220—
+7K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K202503ChromeQuanta System Spa202012—
+9K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+9K253765Vanish ProDdc Technologies, Inc.20260—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241527Pastelle ProWontech Co., Ltd.20253—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+9K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+9K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+10K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+10K250165PastelleWontech Co., Ltd.20250—