510(k) Report

Devices descending from K982940

1,526 later devices reach Lightsheer Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250125LMNT O2Xplr, Ltd.20250—
+7K242241SunnyShenB Co., Ltd.20250—
+7K240311JETT Medical IICompex, Spol, S.R.O.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V…Zhuzhou Goldenhot Medical Technology Co., Ltd.20240—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+7K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+7K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)Ulike Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241881IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd.20241—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241102Luna 4 plusForeo, Inc.20245—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+7K240248Volnewmer™Classys, Inc.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+7K23299210THERMATentech, Inc.20230—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+7K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+7K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd.20234—
+7K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+7K232183IPL Hair Removal Device, Model (s): T1, T2, T3, T7, T10Shenzhen Koli Technology Co.,Ltd20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+7K230663DensityJeisys Medical, Inc.20232—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+7K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K223147myLEDmaskMyblend20234—
+7K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+7K230097IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd.20238—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20220—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K221989The OligioWontech Co., Ltd.20222—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.20220—
+7K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd.20221—
+7K212561MTX-C1Ilooda Co,., Ltd.20220—
+7K221761SoleaConvergent Dental, Inc.202201
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO, Ltd.20220—
+7K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd.20228—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+7K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.20222—
+7K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+7K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+7K213428EdgeProBiolase, Inc.20210—
+7K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K202780SectumNeauvia North America20211—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192430Epic 980Biolase, Inc.20195—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—