FDA 510(k) Applications for Medical Device Product Code "OHT"
(Light Based Over-The-Counter Hair Removal)

FDA 510(k) Number Applicant Device Name Decision Date
K243036 Bestway Plastic And Metal Products Ltd. IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL 06/15/2025
K172791 Conair Corporation Lumilisse IPL Hair Remover 01/18/2018
K190366 CyDen Limited BRAUN Silk Expert Pro 3 03/18/2019
K211994 CyDen Limited Braun Silk.expert Mini 07/28/2021
K190354 CyDen Limited BRAUN Silk.expert Pro 5 03/18/2019
K230911 CyDen Limited Braun Skin i.expert 04/27/2023
K130315 CYDEN LIMITED IPULSE HAIR REMOVAL SYSTEM 07/12/2013
K163552 CYDEN LIMITED iPulse SmoothSkin BARE Hair Removal Device 03/03/2017
K160968 CYDEN LIMITED iPulse SmoothSkin Gold Hair Removal Device 04/14/2016
K162231 CYDEN LIMITED iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert 11/16/2016
K122280 CYDEN LIMITED IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM 10/23/2012
K192010 CyDen Limited SmoothSkin BARE+ 09/24/2019
K200184 CyDen Limited SmoothSkin Pure 02/21/2020
K233782 CyDen Limited SmoothSkin Pure Adapt (SSG3) 12/20/2023
K213692 CyDen Limited SmoothSkin Pure Mini 01/26/2022
K243362 CyDen Limited SmoothSkin Pure Switch (SSC1) 11/27/2024
K240587 CyDen Limited SmoothSkin Pure Unplugged (SSB3) 03/29/2024
K250253 Dongguan Boyuan Intelligent Technology Co.,Ltd IPL Hair Removal Device (KCA511/KCA516/KCA522) 05/06/2025
K240282 Dongguan Boyuan Intelligent Technology Co.,Ltd. IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) 04/03/2024
K212318 Dongguan Define Beauty Electronic Technology Co. Ltd IPL Hair Removal 01/14/2022
K232056 Dongguan Lide Electric Appliance Co., Ltd IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 10/06/2023
K250384 EL Global Trade Ltd IPL400 05/23/2025
K172181 EL Global Trade Ltd micro IPL 10/13/2017
K161089 EL GLOBAL TRADE LTD sensiLight Mini 07/08/2016
K140527 EL GLOBAL TRADE LTD. SENSILIGHT MINI 07/31/2014
K183260 EL Global Trade Ltd. Sensilight Pro / Pistol IPL 03/18/2019
K140381 EL GLOBAL TRADE LTD. SENSILIGHT/ SENSILIGHT PLUS 08/08/2014
K231977 Foreo Inc. PEACH 2, PEACH 2 Duo, PEACH 2 go 09/25/2023
K231717 Foshan Jindi Electric Appliance Co.,Ltd IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 09/06/2023
K243017 Foshan Newface Electronic Technology Co., Ltd. IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) 05/06/2025
K213041 Glan Electronics Co., Ltd. IPL Hair Removal, Model: OBT-02 11/18/2021
K210376 Guangzhou Haoxingwan Technology Co., Ltd. Superior Hair Remover 10/07/2021
K131870 HOME SKINOVATIONS LTD. GLIDE DEVICE 08/14/2013
K141242 HOME SKINOVATIONS LTD. GLIDE DEVICE 10/17/2014
K103184 HOME SKINOVATIONS LTD. SILK'N FLASH N GO 11/10/2010
K171433 Home Skinovations Ltd. Silk'n Infinity 08/11/2017
K181121 Home Well Trading LTD Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro 06/28/2018
K181734 Home Well Trading LTD Beurer IPL 8500 device/ IPL VelvetSkin Pro 09/19/2018
K222432 Hunan Guangye Biotechnology Co., Ltd. IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 10/11/2022
K213830 Iluminage Beauty Co., Limited Home use hair removal device, model: Precise Touch Pro 02/01/2022
K143003 Ipulse Limited iPulse Smooth Skin Gold Hair Removal System 06/18/2015
K230025 Ivylaser (Beijing) Technology Co., Ltd. IVYLASER Handhold Hair Removal Machine 07/03/2023
K190820 Kam Yuen Plastic Products Ltd Aimanfun Lumea Comfort 10/02/2019
K230107 Kam Yuen Plastic Products Ltd. Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 04/05/2023
K163173 Liaoning Sidey Optoelectronics Technologies Co., Ltd. Handheld Diode Laser for Hair Removal 02/08/2017
K232274 Lumenessa Corp IPL hair removal device 09/28/2023
K181568 Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt IPL Salon Hair Reduction System 09/11/2018
K230473 Miley Technology(Hebei) Co., Ltd. IPL Hair Removal Device Models: MLY-T069 06/15/2023
K223524 MorLaser Shenzhen Co., Ltd. IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 02/16/2023
K250131 Mustech Electronics Co., Limited IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) 03/19/2025
K170269 Oriental Inspiration Limited Hee HR Mini 05/03/2017
K060839 PALOMAR MEDICAL TECHNOLOGIES, INC. ABC HAIR REMOVAL SYSTEM 12/07/2006
K243453 Philips Consumer Lifestyle B.V. Philips Lumea IPL 02/10/2025
K241120 Qiaocheng Li (Dongguan) Medical Instruments Co., LTD Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) 06/24/2024
K173813 Shen Zhen CosBeauty Co., Ltd IPL Hair Removal Device Joy Version 09/07/2018
K161428 SHEN ZHEN COSBEAUTY CO.,LTD. PerfectSmooth 03/23/2017
K211185 Shenzhen Beauty Every Moment intelligent electric Co., Ltd. IPL Home Use Hair Removal Device 12/20/2021
K240583 Shenzhen Beauty Every Moment intelligent electric Co., Ltd. IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) 06/18/2024
K211922 Shenzhen Beauty Every Moment intelligent electric Co.,Ltd. IPL Home Use Hair Removal Device 09/20/2021
K221001 Shenzhen Beauty Every Moment intelligent electric Co.,Ltd. IPL Home Use Hair Removal Device 05/12/2022
K232939 Shenzhen Borria Technology Co., Ltd IPL Hair Removal Device 12/15/2023
K213020 Shenzhen Borria Technology Co.,Ltd IPL hair removal machine 12/16/2021
K192432 Shenzhen Bosidin Technology Co., Ltd. IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 11/08/2019
K230097 Shenzhen BSX Technology Electronics Co., Ltd. IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 04/06/2023
K212897 Shenzhen Century Dongyuan Technology Co Ltd. IPL Hair Removal Device, model: AI01 11/04/2021
K221466 Shenzhen Century Dongyuan Technology Co Ltd. IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 08/12/2022
K251000 Shenzhen Chuangtong Yigou Technology Co., Ltd Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) 06/30/2025
K221643 Shenzhen Desida Technology Co., Ltd. Hair Removal Device (Model: IPL-D26, IPL-D19) 10/21/2022
K221635 Shenzhen Desida Technology Co., Ltd. IPL sapphire ice cooling hair remove device 08/31/2022
K212881 Shenzhen Fansizhe Science And Technology Co., Ltd Intense Pulsed Light (IPL) System 04/11/2022
K221569 Shenzhen Fansizhe Science And Technology Co., Ltd Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K 06/30/2022
K223928 Shenzhen Fansizhe Science And Technology Co., Ltd Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K 03/28/2023
K251173 Shenzhen Fansizhe Science and Technology Co., Ltd. Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) 07/14/2025
K222316 Shenzhen Goodwind Technology Development CO., LTD IPL Hair Removal Device 09/28/2022
K242595 Shenzhen Greatro Electronic Technology Co., Ltd Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) 11/07/2024
K232932 Shenzhen Greatro Electronic Technology Co., Ltd. Intense Pulse Light Therapeutic Apparatus 12/04/2023
K180383 Shenzhen GSD Tech Co., Ltd Light based hair removal device 05/11/2018
K230060 Shenzhen GSD Tech Co., Ltd. Light Based Hair Removal Device GP592 03/03/2023
K242197 Shenzhen Huaruibo Electric Appliances Co., Ltd IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) 10/17/2024
K230739 Shenzhen IONKA Medical Technology Co., Ltd. Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 05/26/2023
K222537 Shenzhen Ishine Technology Company Limited IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi 10/14/2022
K242710 Shenzhen Jianchao Intelligent Technology Co., Ltd. Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) 12/06/2024
K232575 Shenzhen Jianchao Intelligent Technology Co., Ltd. Hair Removal Device, Model(s): R2815-G Pro, R2815-G 11/20/2023
K240016 Shenzhen Jianrong Biomedical Electronics Co., Ltd IPL Hair Removal Device (YT01,YT02,YT03,YT04) 07/10/2024
K230360 Shenzhen Jizhimei Technology Co., Ltd. IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 04/10/2023
K220669 Shenzhen Junbobeauty Technology Co., Ltd. IPL HAIR REMOVAL HANDSET, Model: IPL-666 05/16/2022
K241881 SHENZHEN JUNMEI TECHNOLOGY CO., LTD. IPL Hair Removal Device (JM-843, JM-865, JM-638) 08/29/2024
K232183 Shenzhen Koli Technology Co.,Ltd IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 09/22/2023
K212697 Shenzhen Leaflife Technology Co., Ltd Leaf Smooth 11/19/2021
K230362 Shenzhen Leaflife Technology Co., Ltd Planar LED mate 09/11/2023
K241343 Shenzhen Lescolton Electrical Appliance Co., Ltd IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140) 07/09/2024
K232499 Shenzhen Lescolton Electrical Appliance Co., Ltd. IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) 10/11/2023
K221451 Shenzhen Lizbella Technology Co.,Ltd IPL hair removal 08/01/2022
K220248 Shenzhen Mareal Tech Co., Ltd Home use hair removal device 07/01/2022
K172883 Shenzhen Mareal Tech Co., Ltd Home Use Hair Removal Device/T1, T2, T3 02/12/2018
K232846 Shenzhen MEIK Beauty Industry Co., Ltd Light Based Hair Removal Device 12/07/2023
K180016 Shenzhen Mismon Technology Co., Ltd Home Use IPL Beauty Device 03/20/2018
K210311 Shenzhen Mismon Technology Co., Ltd. Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. 07/23/2021
K221679 Shenzhen Mywin Technology Co., Ltd. IPL Hair Remover, Model: G993, G996, G998 and G885 07/07/2022
K222598 Shenzhen Noble Smart Manufacturing Tech Co. Ltd IPL Hair Removal Device 11/17/2022
K220645 Shenzhen Qianyu Technology Co., Ltd. Hand-held IPL device (JOVS Hair Removal Device) 04/27/2022
K214113 Shenzhen Qianyu Technology Co., Ltd. Hand-held IPL device(JOVS Graphene Hair Removal Device) 03/28/2022
K231800 Shenzhen Qianyu Technology Co., Ltd. IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 09/07/2023
K220927 Shenzhen Qiaochengli Technology Co., Ltd. IPL Hair Removal 06/02/2022
K211174 Shenzhen Qiaochengli Technology Co., Ltd. IPL Hair Removal 09/01/2021
K221246 Shenzhen Semlamp Intelligent Technology Co., Ltd IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) 07/07/2022
K240969 Shenzhen Semlamp Intelligent Technology Co., Ltd IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) 05/31/2024
K240093 Shenzhen Shuge Medical Beauty Devices Co., Ltd. IPL Home Use Hair Removal Device (SJ15) 04/24/2024
K232845 Shenzhen Siken 3D Technology Development Co., Ltd. IPL Cooling Hair Removal Device 11/14/2023
K222710 Shenzhen Siken 3D Technology Development Co., Ltd. IPL Cooling Hair Removal Device 12/01/2022
K250938 Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) 05/23/2025
K241998 Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) 12/13/2024
K250942 Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) 07/11/2025
K241205 Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) 09/09/2024
K233679 Shenzhen Ulike Smart Electronics Co.,Ltd IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG) 01/05/2024
K233664 Shenzhen Ulike Smart Electronics Co.,Ltd IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) 01/11/2024
K233887 Shenzhen Ulike Smart Electronics Co.,Ltd IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 D 01/22/2024
K221002 Shenzhen Ulike Smart Electronics Co.,Ltd IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C 06/01/2022
K230122 Shenzhen Ulike Smart Electronics Co.,Ltd IPL Hair Removal Device, Model(s): UI04áSD, UI04áDG 04/10/2023
K223618 Shenzhen Ulike Smart Electronics Co.,Ltd IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD 02/28/2023
K240652 Shenzhen Ulike Smart Electronics Co.,Ltd. Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) 04/04/2024
K251984 Shenzhen Ulike Smart Electronics Co.,Ltd. Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) 07/24/2025
K250194 Shenzhen Ulike Smart Electronics Co.,Ltd. Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) 03/26/2025
K240649 Shenzhen Ulike Smart Electronics Co.,Ltd. Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) 06/21/2024
K242039 Shenzhen Ulike Smart Electronics Co.,Ltd. Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) 11/06/2024
K203510 Shenzhen Weikai Technology CO.,LTD IPL Hair removal 02/26/2021
K232124 Shenzhen Wochuan Electronic Co., Ltd IPL Hair Removal, Model: W-1095, W-1098 09/14/2023
K230549 Shenzhen Xiazhifeng Electronic Co., Ltd. IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG 04/25/2023
K241834 Shenzhen Yang Wo Electronic Co., Ltd IPL Hair Removal Device (BE932C, BE932D, BE932E) 09/23/2024
K250171 Shenzhen Yang Wo Electronic Co., Ltd. IPL Hair Removal Device (BE965A, BE965B, BE965C) 03/19/2025
K230021 Shenzhen Yangyi Technology ., Ltd IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 03/31/2023
K220222 Shenzhen Yuwei Electronic Technology Co., Ltd. IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 04/26/2022
K240264 ShenzhenáMlayáIntelligentáTechnologyáCo.,áLtd. Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) 03/08/2024
K241106 ShenzhenáMlayáIntelligentáTechnologyáCo.,áLtd. Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) 05/22/2024
K183217 Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. IPL Hair Removal Device 02/15/2019
K221553 Ulike Co., Ltd Diamond Air+ (UI04A, UI04B, UI04C) 09/15/2022
K243030 Ulike Co., Ltd. Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) 10/25/2024
K132518 WELLQUEST INTL., INC. NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE 08/17/2014
K142845 Wuhan Lotuxs Technology Co., Ltd SILKPRO laser hair removal system 07/01/2015
K230090 Wuhan Lotuxs Technology Co., Ltd. Diode Laser Hair Removal 04/19/2023
K212314 Zhongshan Bisen Plastic Electronic Products Co., Ltd. IPL Hair Removal Device 10/21/2021
K231215 ZhongShan Qizhe Technology Co., Ltd. IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S 06/26/2023
K231613 Zhuzhou Goldenhot Medical Technology Co., Ltd. Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. 07/31/2023
K243085 Zhuzhou Goldenhot Medical Technology Co.,Ltd. IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) 12/21/2024


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