510(k) Report

Devices descending from K031425

199 later devices reach Gentlewaves Led Photomodulation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+5K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+5K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+5K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K171227StarWalkerFotona D.O.O.20177—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152714Quanta ForteQuanta System Spa201513—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K232236EchoQuanta System Spa20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202172StarWalkerFotona D.O.O.20203—
+6K192856MT OneM&T S.R.L.20202—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K172413MT ONEM&T S.R.L.20175—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K22079410PLTentech Co., Ltd.20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—