Panels › General, Plastic Surgery › Product code OHS · Class 2
Light Based Over The Counter Wrinkle Reduction
Regulation 878.4810
37510(k)s in 12 months (165 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in OHS
| Company | 510(k)s | Recalls |
|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 15 | 0 |
| Led Technologies, Inc. | 11 | 0 |
| Light Tree Ventures Europe B.V. | 7 | 0 |
| Led Intellectual Properties, LLC | 6 | 0 |
| Guangdong Newdermo Biotech Co., Ltd. | 4 | 0 |
| Foreo, Inc. | 3 | 0 |
| iSMART Developments, Ltd. | 3 | 0 |
| Premier North America, Inc. | 3 | 0 |
| Quasar Bio-Tech, Inc. | 0 | 3 |
| Shenzhen Kaiyan Medical CO , Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K262752 | Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., CN | OHS |
| Oct 19, 2026 | K262932 | AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) Shenzhen Accompany Technology Co., Ltd., CN | OHS |
| Aug 31, 2026 | K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS B Kam Yuen Plastic Products , Ltd., CN | OHS |
| Aug 10, 2026 | K261602 | Eye Recovery Pro (PH-e03) Shenzhen Goodwind Technology Development Co., Ltd., CN | OHS |
| Aug 7, 2026 | K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) Shenzhen Chuangtong Yigou Technology Co., Ltd., CN | OHS |
| Aug 4, 2026 | K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+J Shenzhen Qianyu Technology Co., Ltd., CN | OHS |
| Aug 4, 2026 | K261496 | LED Light Therapy Masks (PE748, PE749, PE756) Duplex International Trading Limited, CN | OHS |
| Jul 31, 2026 | K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) Led Intellectual Properties, LLC | OHS |
| Jul 24, 2026 | K260598 | 5 Wavelength LED Facemask (TN2508) iSMART Developments, Ltd., GB | OHS |
| Jul 15, 2026 | K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457 Dongguan Miqiang Technology Co., Ltd., CN | OHS |
| Jul 1, 2026 | K261473 | Chromix Termosalud S.L., ES | OHS |
| Jun 29, 2026 | K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) Guangdong Newdermo Biotech Co., Ltd., CN | OHS |
| Jun 18, 2026 | K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) Guangdong Newdermo Biotech Co., Ltd., CN | OHS |
| Jun 16, 2026 | K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jun 3, 2026 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) The Beauty Tech Group, Ltd., GB | OHS |
| May 12, 2026 | K260415 | myLEDmask 2 (MJ-144) Light Tree Ventures Europe B.V., NL | OHS |
| Apr 22, 2026 | K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) NOOANCE, FR | OHS |
| Mar 23, 2026 | K260202 | LED Light Therapy Masks (LumiLips FAC07NA) Guangdong Newdermo Biotech Co., Ltd., CN | OHS |
| Mar 16, 2026 | K260511 | Ulike Reglow Light Therapy Device (UM10) Shenzhen Ulike Smart Electronics Co., Ltd., CN | OHS |
| Mar 16, 2026 | K254079 | LED Light Therapy Mask (Models: T2, RLD10) Shenzhen Desida Technology Co., Ltd., CN | OHS |
| Mar 3, 2026 | K253874 | LED Therapy Light (COB1400, HP1800PRO) Shenzhen Hanhua Opto Co., Ltd., CN | OHS |
| Feb 20, 2026 | K253683 | FAQ (LED Panel); FAQ (Dual LED Panel) Foreo, Inc. | OHS |
| Feb 12, 2026 | K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) SZ KKS Silicone&Electronic Co., Ltd., CN | OHS |
| Jan 30, 2026 | K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F221 Shenzhen Jianchao Intelligent Technology Co., Ltd., CN | OHS |
| Jan 28, 2026 | K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jan 23, 2026 | 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., CN | OHS |
| Dec 24, 2025 | 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., CN | OHS |
| Dec 24, 2025 | K253279 | Feather/numiere 05 06 07 (05) Heat IN A Click, LLC | OHS |
| Dec 23, 2025 | 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., CN | OHS |
| Dec 19, 2025 | K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) Sunglor Technology Co., Ltd., CN | OHS |
| Dec 19, 2025 | K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., CN | OHS |
| Dec 17, 2025 | K252983 | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) Shenzhen Goodwind Technology Development Co., Ltd., CN | OHS |
| Dec 8, 2025 | K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) Guangdong Ace-Tec Co., Ltd., CN | OHS |
| Dec 5, 2025 | 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., CN | OHS |
| Nov 19, 2025 | K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) Sunglor Technology Co., Ltd., CN | OHS |
| Nov 19, 2025 | K252642 | Microcurrent Facial Device (CEC101, EEI101) Shenzhen Dachi Communication Co., Ltd., CN | OHS |
| Nov 13, 2025 | K252308 | LED Beauty Mask (RLBXX) Atop Lighting Co., Ltd., CN | OHS |
| Oct 27, 2025 | K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd, CN | OHS |
| Oct 17, 2025 | K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Th Shenzhen Zhenxing Ruitong Technology Co., Ltd., CN | OHS |
| Oct 16, 2025 | K252093 | Light Therapy Mask (1019055) Merchsource, LLC | OHS |
| Oct 9, 2025 | K252272 | ORA Method LED Gua Sha (GS-04) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Oct 1, 2025 | K252096 | Light Therapy Decollete Mask (1019135) Merchsource, LLC | OHS |
| Oct 1, 2025 | K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) Shenzhen Ulike Smart Electronics Co., Ltd., CN | OHS |
| Sep 12, 2025 | K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) Dongguan Yanxi Technology Co., Ltd., CN | OHS |
| Sep 4, 2025 | K251781 | KALA MINI 2.0 (KALA-04) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Aug 21, 2025 | K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) Shenzhen Fittop Health Technology Co., Ltd., CN | OHS |
| Aug 15, 2025 | K251871 | FEATHER 01 02 03 04 (Model:01) Heat IN A Click, LLC | OHS |
| Aug 14, 2025 | K251012 | TRUDERMAL Pro (ZLD-390) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Aug 7, 2025 | K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) Shenzhen Liyoutong Technology Co., Ltd., CN | OHS |
| Jul 11, 2025 | K250761 | KALA Therapy Wand (Model: KALA-03) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
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