510(k) Report

Devices descending from K885026

767 later devices reach Houva II Uvb through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K090762LEDAQuantel Derma GmbH200946—
+7K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+7K082938EzlaseBiolase Technology, Inc.200850—
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+7K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+8K232236EchoQuanta System Spa20230—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230077LaserMENeauvia North America20232—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K221083Smartlux MiniMedmix Co., Ltd.20222—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+8K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+8K202172StarWalkerFotona D.O.O.20203—
+8K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K181868SHINY RPL SystemIds, Ltd.20181—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K180875Poly RejuvMedtek Skincare, LLC20180—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K1718212 Face / Face EvolutionHeat IN A Click201858—
+8K180406Ellipse YdunEllipse A/S20180—