Shenzhen Liyoutong Technology Co., Ltd. · Class II · Cleared Aug 7, 2025
| K-number | K251667 |
| Device name | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) |
| Applicant | Shenzhen Liyoutong Technology Co., Ltd. |
| Product code | OHS |
| Device class | Class II |
| Decision date | Aug 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The LED Light Therapy Mask is a wearable home-use phototherapy device consisting of a mask unit, controller, and charging cable. It emits red (630nm), amber (605nm), blue (415nm), and infrared (850nm) light in various combinations to reduce facial wrinkles and treat mild to moderate inflammatory acne.
The device uses lithium battery power supply tested per FDA guidance and IEC 62133-2. It produces the same wavelengths as predicate devices K241857 and K192295 and complies with IEC 60601-2-83 and IEC 62471. Irradiance levels are within the range of predicate and reference devices. The device incorporates Type BF applied part safety features.
ISO 10993-1:2018 (biological evaluation), IEC 60601-1:2020 (general medical equipment safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1-11:2020 (home healthcare environment), IEC 60601-2-83:2022 (home light therapy equipment), and IEC 62471:2006 (photobiological safety).
The indications for use are comparable to predicates K241857 and K192295. The device uses identical wavelengths to predicates, ensuring no new safety or effectiveness issues. Although irradiance values differ slightly, they remain within the documented range of predicate and reference devices and comply with applicable safety standards. Dimension and weight differences are insignificant and do not affect safety or performance.
View the full FDA submission: accessdata.fda.gov