510(k) Report

Devices descending from K994014

1,283 later devices reach Esc Intense Pulsed Light Systems: Epilight and Multilight through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+6K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+6K082938EzlaseBiolase Technology, Inc.200850—
+6K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+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—
+7K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+7K253504Volnewmer™Classys, Inc.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+7K253750BTL-785NEHBTL Industries, Inc.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+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—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+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—
+7K244060eCO2 3DLutronic Corporation20250—
+7K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+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—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+7K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.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—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+7K242532BTL-785BNF-EBTL Industries, Inc.20241—
+7K240897CellinewVIOL Co., Ltd.20240—
+7K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242349FoLixLumenis Be, Ltd.20240—
+7K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+7K240313Oligio XWontech Co., Ltd.20241—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+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—
+7K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232236EchoQuanta System Spa20230—
+7K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+7K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+7K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+7K223727LavieenWontech Co., Ltd.20234—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230293TheraFace MaskTherabody, Inc.202316—
+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—
+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—
+7K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K210084SilkroHironic Co., Ltd.20223—
+7K213261EpilMENeauvia North America20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+7K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K212155TheraFace LEDTheragun, Inc.202142—
+7K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—