510(k) Report

Devices descending from K990417

1,062 later devices reach Dermacool through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+7K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+7K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+7K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+7K252187Aura Glide (FC40)Aura Medical, LLC20250—
+7K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251843Erchonia EVRLErchonia Corporation20250—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+7K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+7K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+7K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+7K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242349FoLixLumenis Be, Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241656Eneka SelectifTermosalud20241—
+7K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+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—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+7K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+7K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232236EchoQuanta System Spa20230—
+7K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+7K223727LavieenWontech Co., Ltd.20234—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K230293TheraFace MaskTherabody, Inc.202316—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+7K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+7K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+7K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+7K212155TheraFace LEDTheragun, Inc.202142—
+7K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K212238TheraFace MicrocurrentTheragun, Inc.20210—
+7K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K190443MMSphereGalactic Beauty, LLC201942—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K170984LG Beauty Led MaskLg Electronics201793—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—