510(k) K251667
- Device
- LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
- Applicant
- Shenzhen Liyoutong Technology Co., Ltd.
- 510(k) number
- K251667
- Product code
- OHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-07
- Date received
- 2025-05-30
- Regulation
- 878.4810
- Classification name
- Light Based Over The Counter Wrinkle Reduction
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zhenwen Lai
- Address
- 705,7th Floor ,Bldg. H,Bantian International Ctr., #5 Huanch South Rd., Ma'An Tang Community, Bantian St., Longgang Dist. Shenzhen CN
FDA Registration Numbers#
- 3013423303
- 3016076077
- 3004450661
- 3015646995
- 3010677917
- 3024892917
- 3030194742
- 3017555752
- 3037031835
- 3027645761
- 3030234143
- 3008345424
- 3018994966
- 3039304811
- 9617486
- 1222304
- 3036720861
- 3016750352
- 3037341611
- 3016171836
- 3043729119
- 3033847811
- 3009102830
- 3022327202
- 3015783545
- 3014545271
- 3043165181
- 3038214786
- 3007554929
- 3015287734
- 3004126239
- 3017618922
- 3042131929
- 3039443706
- 3013481783
- 3017103444
- 3033850491
- 3038373471
- 3012512142
- 3012104022
- 3015603281
- 3035785623
- 1318319
- 3011564440
- 3030234086
- 3019015047
- 3012113199
- 3019864920
- 3031595583
- 3004839404
- 3013397886
- 3013689783
- 3015168585
- 3010402752
- 3027651556
- 3016055197
- 3017649333
- 3023339107
- 3023339103
- 1832894
- 3015313684
- 3010027944
- 3007744197
- 3008592814
- 3008929787
- 3016071154
- 3012470925
- 3021282471
- 3006546131
- 3012294783
- 3029944286
- 3017382141
- 3017706553
- 3029972385
- 3016496662
- 3014386328
- 3026890286
- 3017422691
- 3006459199
Source Documents#
Other 510(k) Records For Product Code OHS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K261473 | Chromix | Termosalud S.L. | 2026-07-01 |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 |
| 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 |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 |
| K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026-06-03 |
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | 2026-05-12 |
| K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | 2026-04-22 |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | 2026-03-16 |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-03-16 |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | 2026-03-03 |
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo, Inc. | 2026-02-20 |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. | 2026-02-12 |
| 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 |