FDA Product Code
FDA Product Code OHS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 163 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. | 2026-08-31 | Traditional | PDF ↗ |
| K261602 | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | 2026-08-10 | Traditional | PDF ↗ |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 | Traditional | PDF ↗ |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | 2026-08-04 | Traditional | PDF ↗ |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | Shenzhen Qianyu Technology Co., Ltd. | 2026-08-04 | Traditional | PDF ↗ |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | 2026-07-31 | Traditional | PDF ↗ |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | 2026-07-24 | Traditional | PDF ↗ |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. | 2026-07-15 | Traditional | PDF ↗ |
| K261473 | Chromix | Termosalud S.L. | 2026-07-01 | Traditional | PDF ↗ |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 | Traditional | PDF ↗ |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 | Traditional | PDF ↗ |
| K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026-06-03 | Traditional | PDF ↗ |
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | 2026-05-12 | Traditional | PDF ↗ |
| K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | 2026-04-22 | Traditional | PDF ↗ |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 | Traditional | PDF ↗ |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-03-16 | Special | PDF ↗ |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | 2026-03-16 | Traditional | PDF ↗ |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | 2026-03-03 | Traditional | PDF ↗ |
| K253683 | FAQ (LED Panel); FAQ (Dual LED Panel) | Foreo, Inc. | 2026-02-20 | Traditional | PDF ↗ |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. | 2026-02-12 | Traditional | PDF ↗ |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026-01-30 | Traditional | PDF ↗ |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-28 | Traditional | PDF ↗ |
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co., Ltd. | 2026-01-23 | Traditional | PDF ↗ |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 2025-12-24 | Traditional | PDF ↗ |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | 2025-12-24 | Traditional | PDF ↗ |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. | 2025-12-23 | Traditional | PDF ↗ |
| K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K252983 | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. | 2025-12-17 | Traditional | PDF ↗ |
| K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) | Guangdong Ace-Tec Co., Ltd. | 2025-12-08 | Traditional | PDF ↗ |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-05 | Traditional | PDF ↗ |
| K252642 | Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | 2025-11-19 | Traditional | PDF ↗ |
| K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. | 2025-11-19 | Traditional | PDF ↗ |
| K252308 | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | 2025-11-13 | Traditional | PDF ↗ |
| K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 2025-10-27 | Traditional | PDF ↗ |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. | 2025-10-17 | Traditional | PDF ↗ |
| K252093 | Light Therapy Mask (1019055) | Merchsource, LLC | 2025-10-16 | Traditional | PDF ↗ |
| K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-09 | Traditional | PDF ↗ |
| K252096 | Light Therapy Decollete Mask (1019135) | Merchsource, LLC | 2025-10-01 | Traditional | PDF ↗ |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-10-01 | Traditional | PDF ↗ |
| K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. | 2025-09-12 | Traditional | PDF ↗ |
| K251781 | KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-09-04 | Traditional | PDF ↗ |
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | 2025-08-21 | Traditional | PDF ↗ |
| K251871 | FEATHER 01 02 03 04 (Model:01) | Heat IN A Click, LLC | 2025-08-15 | Traditional | PDF ↗ |
| K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-08-14 | Traditional | PDF ↗ |
| K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., Ltd. | 2025-08-07 | Traditional | PDF ↗ |
| K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-07-11 | Traditional | PDF ↗ |
| K250966 | CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-25 | Traditional | PDF ↗ |
| K250880 | LED LIGHT MASK (A093) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. | 2025-06-20 | Traditional | PDF ↗ |
| K243978 | LED Facial Mask | Shenzhen Sunsred Technology Co.,Ltd | 2025-06-20 | Traditional | PDF ↗ |
| K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | Shenzhen Sungrow Led Technology Co., Ltd. | 2025-06-09 | Traditional | PDF ↗ |
| K251042 | Light Therapy System (M500, L6) | Guangzhou Ahead Intelligent Technology Co., Ltd. | 2025-06-06 | Traditional | PDF ↗ |
| K250581 | KALA Red Light Face Mask (KALA-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-30 | Traditional | PDF ↗ |
| K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-22 | Traditional | PDF ↗ |
| K244020 | Wrinkle Treatment Device (JM1, JM2B) | Shenzhen Qianyu Technology Co., Ltd. | 2025-05-01 | Traditional | PDF ↗ |
| K242151 | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-04-08 | Traditional | PDF ↗ |
| K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. | 2025-04-07 | Traditional | PDF ↗ |
| K250125 | LMNT O2 | Xplr , Ltd. | 2025-03-24 | Traditional | PDF ↗ |
| K250413 | Aglaia LED Beauty Device (BP-D2309) | Shenzhen Perfect Idea Technology Limited | 2025-03-18 | Traditional | PDF ↗ |
| K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-03-03 | Traditional | PDF ↗ |
| K243330 | LYMA Laser PRO | Lyma Life , Ltd. | 2025-02-21 | Traditional | PDF ↗ |
| K242593 | CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-02-14 | Traditional | PDF ↗ |
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | Shenzhen Rainbow Technology Co., Ltd. | 2025-01-28 | Traditional | PDF ↗ |
| K243492 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-01-10 | Traditional | PDF ↗ |
| K242789 | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) | Dongguan Laiguang Electronic Technology Co., Ltd. | 2025-01-02 | Traditional | PDF ↗ |
| K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K242700 | 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) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-12-19 | Traditional | PDF ↗ |
| K242796 | CryoGlow (FW3XXXX) | Sharkninja Operating, LLC | 2024-11-27 | Traditional | PDF ↗ |
| K242638 | LED Light Therapy Machine (G1, G3, G4, G6) | Shenzhen Walton Technology Co., Ltd. | 2024-11-27 | Traditional | PDF ↗ |
| K242382 | décoLITE LED Device | iSMART Developments, Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024-10-28 | Traditional | PDF ↗ |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024-10-11 | Traditional | PDF ↗ |
| K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-09-27 | Traditional | PDF ↗ |
| K241102 | Luna 4 plus | Foreo, Inc. | 2024-08-20 | Traditional | PDF ↗ |
| K241203 | 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) | Dongguan Hunter Electronic Technology Co., Ltd. | 2024-07-25 | Traditional | PDF ↗ |
| K240378 | FAQ 201, FAQ 202 | Foreo, Inc. | 2024-04-19 | Traditional | PDF ↗ |
| K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-04-10 | Traditional | PDF ↗ |
| K240360 | Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. | 2024-04-05 | Traditional | PDF ↗ |
| K233862 | NUNA LUX (NUNL528) | Premier North America, Inc. | 2024-03-01 | Traditional | PDF ↗ |
| K233114 | LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) | Shenzhen Idea Light Limited | 2024-01-12 | Traditional | PDF ↗ |
| K233556 | LED Eye mask (EY-20R, A20, EY-20N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-01-04 | Traditional | PDF ↗ |
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023-12-13 | Traditional | PDF ↗ |
| K232795 | Led Mask Platinum Exclusive MD | Stg24 Co., Ltd. | 2023-12-07 | Traditional | PDF ↗ |
| K223919 | B.Light Clear Evo and B.Light Restore Evo | Bemer Int AG | 2023-09-23 | Traditional | PDF ↗ |
| K231555 | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | iSMART Developments, Ltd. | 2023-07-27 | Traditional | PDF ↗ |
| K230293 | TheraFace Mask | Therabody, Inc. | 2023-06-09 | Traditional | PDF ↗ |
| K223893 | Infrared Heat (Model: E0221) | Light Tree Ventures Europe B.V. | 2023-05-16 | Traditional | PDF ↗ |
| K223147 | myLEDmask | Myblend | 2023-05-14 | Traditional | PDF ↗ |
| K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023-05-05 | Traditional | PDF ↗ |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023-04-28 | Traditional | PDF ↗ |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) | Light Tree Ventures Europe B.V. | 2023-03-15 | Traditional | PDF ↗ |
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023-02-23 | Traditional | PDF ↗ |
| K222685 | NIRA Model 2 | Dermal Photonics Corp | 2023-02-08 | Traditional | PDF ↗ |
| K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | Led Technologies, Inc. | 2022-12-21 | Special | PDF ↗ |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | Light Tree Ventures Europe B.V. | 2022-12-20 | Traditional | PDF ↗ |
| K221444 | LED Eye Perfector, model: EY-36A, EY-36B | Light Tree Ventures Europe B.V. | 2022-12-08 | Traditional | PDF ↗ |
| K221946 | LED Light Therapy Mask (model: MK66R-B) | Light Tree Ventures Europe B.V. | 2022-11-22 | Traditional | PDF ↗ |
| K223278 | easy Claire | Y & J Bio Co., Ltd. | 2022-11-17 | Special | PDF ↗ |
| K222377 | Led Mask Platinum Md | Cellreturn Co., Ltd. | 2022-11-03 | Traditional | PDF ↗ |
Product code OHS · Class II · General, Plastic Surgery. Data: openFDA.