FDA 510(k) Applications for Medical Device Product Code "OHS"
(Light Based Over The Counter Wrinkle Reduction)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K212275 | Aesthetic Technology Ltd. | Dermalux Flex MD | 11/18/2021 |
| K223919 | Bemer INT. AG | B.Light Clear Evo and B.Light Restore Evo | 09/23/2023 |
| K171323 | Biophotas Inc | BIOPHOTAS CELLUMA3 | 09/01/2017 |
| K132613 | BIORENEW LABS, LLC | SONILASE LIGHT THERAPY DEVICE | 02/05/2014 |
| K202442 | Carewear Corp. | Carewear Firefly Wrinkle Reduction | 11/19/2020 |
| K120560 | Carol Cole Company | TRINITY WRINKLE REMOVER | 11/06/2012 |
| K212947 | Carol Cole Company dba NuFACE | Trinity Plus Wrinkle Reducer | 04/02/2022 |
| K222377 | CellReturn Co., LTD. | Led Mask Platinum Md | 11/03/2022 |
| K151337 | Centre Light Solutions, LLC | Strialite | 02/24/2016 |
| K111454 | CYNOSURE, INC. | ILUMINAGE DIODE LASER | 07/05/2012 |
| K133473 | CYNOSURE, INC. | ILUMINAGE SKIN SMOOTHING LASER | 01/15/2014 |
| K222685 | Dermal Photonics Corp | NIRA Model 2 | 02/08/2023 |
| K163137 | Dermal Photonics Corporation | NIRA Beauty Skin Laser | 07/12/2017 |
| K241857 | Dongguan Boyuan Intelligent Technology Co., Ltd. | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | 10/11/2024 |
| K241203 | Dongguan Hunter Electronic Technology Co., Ltd. | PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) | 07/25/2024 |
| K242789 | Dongguan Laiguang Electronic Technology Co.,Ltd. | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) | 01/02/2025 |
| K214101 | Duplex International Trading Limited | Project E Beauty LED Light Therapy Mask (Model: PE730) | 03/23/2022 |
| K124064 | ESPANSIONE MARKETING SPA | YOUNG AGAIN | 12/19/2013 |
| K240378 | Foreo Inc. | FAQÖ 201, FAQÖ 202 | 04/19/2024 |
| K241102 | Foreo Inc. | Luna 4 plus | 08/20/2024 |
| K250880 | Foshan Guangyu Weilai Medical Equipment Co., Ltd. | LED LIGHT MASK (A093) | 06/20/2025 |
| K190443 | Galactic Beauty, LLC | MMSphere | 06/24/2019 |
| K201107 | GTG Wellness Co., Ltd. | Opera Lebody (Gold), Opera Lebody (Zafiro) | 06/22/2020 |
| K223544 | Guangdong Newdermo Biotech Co.,Ltd | LED light therapy mask (FM-01, FM-02, FM-03) | 02/23/2023 |
| K251042 | Guangzhou Ahead Intelligent Technology Co., Ltd. | Light Therapy System (M500, L6) | 06/06/2025 |
| K110301 | HOME SKINOVATIONS LTD. | SILK'N FX | 08/19/2011 |
| K162784 | Home Skinovations Ltd. | Silk'n HST | 03/25/2017 |
| K221151 | Hunan Guangye Biotechnology Co., Ltd. | Beauty LED Mask, Model: KFB265 | 07/19/2022 |
| K242382 | ISMART Developments Ltd | dΘcoLITE LED Device | 11/08/2024 |
| K231555 | iSMART Developments Ltd | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | 07/27/2023 |
| K191629 | iSMART Marketing Svcs Ltd | faceLITE | 09/12/2019 |
| K180856 | Johnson & Johnson Consumer, Inc. | Neutrogena Light Therapy Aging Mask+ | 06/19/2018 |
| K140471 | LA LUMIERE, LLC | PRO X OTC 5 | 01/15/2015 |
| K212771 | LED Intellectual Properties LLC | LightStim Elipsa | 01/26/2022 |
| K120775 | LED INTELLECTUAL PROPERTIES, LLC | LIGHT FOR WRINKLES | 06/04/2012 |
| K101190 | LED INTELLECTUAL PROPERTIES, LLC | LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC | 07/01/2010 |
| K150098 | LED INTELLECTUAL PROPERTIES, LLC | LightStim Professional 2-Panel Light | 04/09/2015 |
| K151336 | LED INTELLECTUAL PROPERTIES, LLC | LightStim Professional 2-Panel Light | 10/23/2015 |
| K183247 | LED Technologies, Inc. | dpl Faceware | 03/14/2019 |
| K171390 | LED Technologies, Inc. | dpl II Panel | 08/03/2017 |
| K180320 | LED Technologies, Inc. | dpl IIa Panel | 04/03/2018 |
| K171386 | LED Technologies, Inc. | dpl SpectraLite | 08/07/2017 |
| K210965 | LED Technologies, Inc. | reVive Light Therapy Essentials | 12/15/2021 |
| K221430 | LED Technologies, Inc. | reVive Light Therapy LED Cleansing System | 07/27/2022 |
| K180445 | LED Technologies, Inc. | reVive Light Therapy LED Ultrasonic Wrinkle System | 05/15/2018 |
| K223482 | LED Technologies, Inc. | reVive Light Therapy« Wrinkle and Acne LED Device | 12/21/2022 |
| K172662 | LED Technologies, Inc. | reVive Perioral | 01/09/2018 |
| K101382 | LED TECHNOLOGIES, LLC | DPL NUVE | 11/09/2010 |
| K141181 | LED TECHNOLOGIES, LLC | NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES | 03/31/2015 |
| K170984 | LG Electronics | LG BEAUTY LED MASK | 08/23/2017 |
| K183671 | LG Electronics, Inc. | LG PRA.L DERMA LED MASK | 01/22/2019 |
| K062991 | LIGHT BIOSCIENCE, LLC | GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE | 02/15/2008 |
| K223893 | Light Tree Ventures Europe B.V. | Infrared Heat (Model: E0221) | 05/16/2023 |
| K221444 | Light Tree Ventures Europe B.V. | LED Eye Perfector, model: EY-36A, EY-36B | 12/08/2022 |
| K221775 | Light Tree Ventures Europe B.V. | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | 12/20/2022 |
| K221946 | Light Tree Ventures Europe B.V. | LED Light Therapy Mask (model: MK66R-B) | 11/22/2022 |
| K230124 | Light Tree Ventures Europe B.V. | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) | 03/15/2023 |
| K230042 | Light Tree Ventures Europe B.V. | Q-Rejuvalight Pro Facewear (Model: P19-0023) | 04/28/2023 |
| K210823 | LYMA Life Ltd. | LYMA Laser | 03/18/2022 |
| K243330 | LYMA Life Ltd. | LYMA Laser PRO | 02/21/2025 |
| K180875 | Medtek Skincare, LLC | POLY REJUV | 09/14/2018 |
| K223147 | myBlend | myLEDmask | 05/14/2023 |
| K200983 | Ningbo Hesi Electric Co., Ltd | Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine | 07/14/2021 |
| K141308 | NUTRA LUXE MD, LLC | NUTRA LIGHT RED | 08/20/2014 |
| K172909 | Omm Imports d/b/a Zero Gravity | ELEVARE, PERFECTIO 4 | 06/07/2018 |
| K152332 | OMM IMPORTS INC DBA ZERO GRAVITY | Perfectio LED infrared device | 02/25/2016 |
| K110735 | PHAROS LIFE CORPORATION | TANDA MAX OTC SYSTEM | 08/03/2011 |
| K072459 | PHOTO THERAPEUTICS, INC. | OMNILUX NEW-U | 03/03/2008 |
| K181659 | Premier North America Inc. | Avologi ENEO | 07/26/2018 |
| K213841 | Premier North America Inc. | ENEO TOTALE (Model: ENEOT947) | 01/06/2022 |
| K233862 | Premier North America Inc. | NUNA LUX (NUNL528) | 03/01/2024 |
| K092460 | PS ADVANCED ENGINEERING | STAR-LITE -LM, MODEL SL8809 | 03/05/2010 |
| K133546 | PS ADVANCED ENGINEERING | STARLITE-OM, LIGHT EFFECTS, THIBIANT | 08/06/2014 |
| K163329 | PULSADERM LLC | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | 04/14/2017 |
| K242796 | SharkNinja Operating, LLC | CryoGlow (FW3XXXX) | 11/27/2024 |
| K241718 | Shenzhen Aozemei Technology Co. Ltd | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | 10/28/2024 |
| K242385 | Shenzhen Borria Technology Co., Ltd | LED Therapy Mask (MN1, M226) | 04/07/2025 |
| K233114 | Shenzhen Idea Light Limited | LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) | 01/12/2024 |
| K202390 | Shenzhen Kaiyan Medical Co Ltd | Aduro Light Beauty Mask | 07/14/2021 |
| K213024 | Shenzhen Kaiyan Medical Co Ltd | Oren LED Perioral Light Therapy System | 12/22/2021 |
| K220168 | Shenzhen Kaiyan Medical Co Ltd | Skin Care Beauty Mask (Model: MJ-06) | 05/17/2022 |
| K250966 | Shenzhen Kaiyan Medical Equipment Co., Ltd | CurrentBody SkinÖ LED Light Therapy Mask Series 2 (MK-90H) | 06/25/2025 |
| K242593 | Shenzhen Kaiyan Medical Equipment Co., Ltd | CurrentBodyÖ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | 02/14/2025 |
| K241947 | Shenzhen Kaiyan Medical Equipment Co., Ltd | EnergyLounger (TY-01) | 03/03/2025 |
| K240089 | Shenzhen Kaiyan Medical Equipment Co., Ltd | Face Patches (MT-12MA, MT-12MC) | 04/10/2024 |
| K241933 | Shenzhen Kaiyan Medical Equipment Co., Ltd | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | 09/27/2024 |
| K250761 | SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD | KALA Therapy Wand (Model: KALA-03) | 07/11/2025 |
| K233556 | Shenzhen Kaiyan Medical Equipment Co., Ltd | LED Eye mask (EY-20R, A20, EY-20N) | 01/04/2024 |
| K232863 | Shenzhen Kaiyan Medical Equipment Co., Ltd | Radiant Renewal Skincare Wand (HD-15, HD-15A) | 12/13/2023 |
| K250532 | Shenzhen Kaiyan Medical Equipment Co., Ltd | Solawave 2-in-1 Skincare Mini (Model: 61043) | 05/22/2025 |
| K242700 | Shenzhen Nuon Medical Equipment Co., Ltd | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) | 12/19/2024 |
| K242151 | Shenzhen Nuon Medical Equipment Co., Ltd | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) | 04/08/2025 |
| K250413 | Shenzhen Perfect Idea Technology Limited | Aglaia LED Beauty Device (BP-D2309) | 03/18/2025 |
| K244020 | Shenzhen Qianyu Technology Co., Ltd. | Wrinkle Treatment Device (JM1, JM2B) | 05/01/2025 |
| K240360 | Shenzhen Qianyu Technology Co., Ltd. | Wrinkle Treatment Device (JM2) | 04/05/2024 |
| K243423 | Shenzhen Rainbow Technology Co., Ltd. | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | 01/28/2025 |
| K243040 | Shenzhen Siken 3D Technology Development Co., Ltd. | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | 12/20/2024 |
| K230351 | Shenzhen SUNGPO HI-TECH Electronic Co., Ltd | LED Facial Mask | 05/05/2023 |
| K250830 | Shenzhen Sungrow LED Technology Co., Ltd. | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | 06/09/2025 |
| K243978 | Shenzhen Sunsred Technology Co.,Ltd | LED Facial Mask | 06/20/2025 |
| K243492 | Shenzhen Ulike Smart Electronics Co., Ltd. | Ulike Reglow Light Therapy Device (UM10) | 01/10/2025 |
| K242638 | Shenzhen Walton Technology Co., Ltd. | LED Light Therapy Machine (G1, G3, G4, G6) | 11/27/2024 |
| K112362 | SILVER BAY, LLC | C100 WRINKLE REDUCTION DEVICE | 08/14/2012 |
| K130225 | SILVERBAY LLC, D/B/A QUASAR BIO-TECH | QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE | 07/11/2013 |
| K232795 | STG24 CO.,LTD. | Led Mask Platinum Exclusive MD | 12/07/2023 |
| K161849 | Tanda Beauty Canada Inc. | Bright | 07/29/2016 |
| K230293 | Therabody, Inc. | TheraFace Mask | 06/09/2023 |
| K212155 | Theragun, Inc. | TheraFace LED | 12/21/2021 |
| K133896 | TROPHY SKIN, INC. | REJUVALITE MD | 11/13/2014 |
| K250125 | XPLR Ltd. | LMNT O2 | 03/24/2025 |
| K213285 | Y & J Bio Co., Ltd. | easy Claire | 03/03/2022 |
| K223278 | Y&J BIO Co., Ltd. | easy Claire | 11/17/2022 |
| K220064 | YRS Group Inc | Synergy Marble (Model: Opasm) | 07/22/2022 |
| K210954 | YRS Group Inc. | Synergy | 06/29/2021 |
| K162489 | Zhongshan Bisen Plastic Electronic Products Co.,Ltd. | RED Light Device | 01/13/2017 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
