510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd.20249—
+7K241343IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A…Shenzhen Lescolton Electrical Appliance Co., Ltd.20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240583IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W…Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+7K241106Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20242—
+7K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+7K240248Volnewmer™Classys, Inc.20241—
+7K240093IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd.20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+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—
+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—
+7K232124IPL Hair Removal, Model: W-1095, W-1098Shenzhen Wochuan Electronic Co., Ltd.20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K231800IPL Hair Removal Device, Model (s): JP1, JR3, JR8, JR9Shenzhen Qianyu Technology Co., Ltd.20231—
+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—
+7K231215IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008SZhongshan Qizhe Technology Co., Ltd.20230—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K223147myLEDmaskMyblend20234—
+7K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+7K230360IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd.202317—
+7K230021IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd.20236—
+7K230060Light Based Hair Removal Device GP592Shenzhen Gsd Tech Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K221989The OligioWontech Co., Ltd.20222—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K212561MTX-C1Ilooda Co,., Ltd.20220—
+7K221761SoleaConvergent Dental, Inc.202201
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221451IPL hair removalShenzhen Lizbella Technology Co.,Ltd20220—
+7K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd.20220—
+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—
+7K221001IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20226—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K213830Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited20220—
+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—
+7K212897IPL Hair Removal Device, model: AI01Shenzhen Century Dongyuan Technology CO, Ltd.20211—
+7K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+7K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+7K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K202780SectumNeauvia North America20211—
+7K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+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—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193266MIINMedico USA, Inc.20210—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—