510(k) Report

Devices descending from K950019

1,568 later devices reach Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+7K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+7K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251327XERFLutronic Corporation202501
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K242241SunnyShenB Co., Ltd.20250—
+7K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K243488Vmat ProTermosalud20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K240311JETT Medical IICompex, Spol, S.R.O.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240248Volnewmer™Classys, Inc.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+7K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+7K23299210THERMATentech, Inc.20230—
+7K233237xeo+ FamilyCutera, Inc.20230—
+7K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+7K232236EchoQuanta System Spa20230—
+7K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+7K232274IPL hair removal deviceLumenessa Corp20230—
+7K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+7K230663DensityJeisys Medical, Inc.20232—
+7K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230077LaserMENeauvia North America20232—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+7K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+7K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+7K223680Eneka ProTermosalud20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K222701MANTA LaserSqualus Med, Ltd.20222—