Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OHS — Predicate Candidate Screening
161 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
255 days90th percentile
161clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 | 85 | 0 |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | 2026-08-04 | 90 | 0 |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy | Shenzhen Qianyu Technology Co., Ltd. | 2026-08-04 | 62 | 0 |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | 2026-07-31 | 87 | 0 |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | 2026-07-24 | 150 | 0 |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, X | Dongguan Miqiang Technology Co., Ltd. | 2026-07-15 | 77 | 0 |
| K261473 | Chromix | Termosalud S.L. | 2026-07-01 | 58 | 0 |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Ches | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 | 90 | 0 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03B | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-18 | 87 | 0 |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 | 182 | 0 |
| K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026-06-03 | 90 | 0 |
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | 2026-05-12 | 92 | 0 |
| K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | 2026-04-22 | 92 | 0 |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 | 59 | 0 |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-03-16 | 27 | 0 |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | 2026-03-16 | 88 | 0 |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | 2026-03-03 | 89 | 0 |
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo, Inc. | 2026-02-20 | 91 | 0 |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks- | SZ KKS Silicone&Electronic Co., Ltd. | 2026-02-12 | 59 | 0 |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026-01-30 | 60 | 0 |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-28 | 163 | 0 |
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-0 | Shenzhen Rainbow Technology Co., Ltd. | 2026-01-23 | 60 | 0 |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 2025-12-24 | 86 | 0 |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W | Shenzhen Saidi Light Therapy Technology Co., Ltd. | 2025-12-24 | 85 | 0 |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJ | Dongguan Yijiaming Technology Co., Ltd. | 2025-12-23 | 89 | 0 |
| K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co., Ltd. | 2025-12-19 | 87 | 0 |
| K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19 | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | 2025-12-19 | 88 | 0 |
| K252983 | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. | 2025-12-17 | 90 | 0 |
| K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4 | Guangdong Ace-Tec Co., Ltd. | 2025-12-08 | 81 | 0 |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-05 | 150 | 0 |
| K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. | 2025-11-19 | 57 | 0 |
| K252642 | Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | 2025-11-19 | 90 | 0 |
| K252308 | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | 2025-11-13 | 112 | 0 |
| K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343 | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 2025-10-27 | 118 | 0 |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LE | Shenzhen Zhenxing Ruitong Technology Co., Ltd. | 2025-10-17 | 88 | 0 |
| K252093 | Light Therapy Mask (1019055) | Merchsource, LLC | 2025-10-16 | 105 | 0 |
| K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-09 | 79 | 0 |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-10-01 | 110 | 0 |
| K252096 | Light Therapy Decollete Mask (1019135) | Merchsource, LLC | 2025-10-01 | 90 | 0 |
| K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. | 2025-09-12 | 60 | 0 |
| K251781 | KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-09-04 | 85 | 0 |
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-0 | Shenzhen Fittop Health Technology Co., Ltd. | 2025-08-21 | 90 | 0 |
| K251871 | FEATHER 01 02 03 04 (Model:01) | Heat IN A Click, LLC | 2025-08-15 | 58 | 0 |
| K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-08-14 | 134 | 0 |
| K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., Ltd. | 2025-08-07 | 69 | 0 |
| K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-07-11 | 120 | 0 |
| K250966 | CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-25 | 86 | 0 |
| K243978 | LED Facial Mask | Shenzhen Sunsred Technology Co.,Ltd | 2025-06-20 | 179 | 0 |
| K250880 | LED LIGHT MASK (A093) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. | 2025-06-20 | 88 | 0 |
| K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13 | Shenzhen Sungrow Led Technology Co., Ltd. | 2025-06-09 | 82 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda