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 |
| 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 |
| K213692 | CyDen Limited | SmoothSkin Pure Mini | 01/26/2022 |
| 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 |
| 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 |
| 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 |
| K170269 | Oriental Inspiration Limited | Hee HR Mini | 05/03/2017 |
| K060839 | PALOMAR MEDICAL TECHNOLOGIES, INC. | ABC HAIR REMOVAL SYSTEM | 12/07/2006 |
| 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 |
| 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 |
| 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 |
| 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 |
| K222316 | Shenzhen Goodwind Technology Development CO., LTD | IPL Hair Removal Device | 09/28/2022 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K222710 | Shenzhen Siken 3D Technology Development Co., Ltd. | IPL Cooling Hair Removal Device | 12/01/2022 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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