Shenzhen Kaiyan Medical Equipment Co., Ltd. · Class II · Cleared May 30, 2025
| K-number | K250581 |
| Device name | KALA Red Light Face Mask (KALA-01) |
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Product code | OHS |
| Device class | Class II |
| Decision date | May 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The KALA Red Light Face Mask (KALA-01) is a wearable LED phototherapy device for over-the-counter use. It emits red light (630nm) and near-infrared light (830nm) to treat full-face wrinkles, and blue light (465nm) to treat mild to moderate acne vulgaris of the face. The device consists of a flexible silicone mask containing LEDs connected to a controller with a rechargeable lithium battery, operated for 10 or 20-minute treatment sessions.
The device uses three LED wavelengths: 630nm red, 830nm near-infrared, and 465nm blue light. Mode 1 delivers 20 mW/cm² red and 10 mW/cm² infrared (30 mW/cm² total); Mode 2 delivers 10 mW/cm² blue light. These intensities are comparable to predicate devices K221775 (20–30 mW/cm² for red/infrared) and K241857 (18 mW/cm² blue, similar to subject device's 10 mW/cm²). The device uses a timer and software controller with a rechargeable lithium battery, identical in principle to predicates.
IEC 60601-1:2005/AMD1:2012/AMD2:2020 (general safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances), IEC 60601-1-11:2015/AMD1:2020 (home healthcare environment), IEC 60601-2-57:2011 (non-laser light source equipment), IEC 62471:2006 (photobiological safety), IEC 62366-1 and IEC 60601-1-6 (usability). Biocompatibility tested per ISO 10993-5, ISO 10993-10, and ISO 10993-23.
The subject device is substantially equivalent because it shares the same intended use (wrinkle reduction and acne treatment via LED phototherapy), regulatory classification (Class II), product codes (OHS, OLP), and design principles as predicates K221775 and K241857. The light wavelengths and intensities fall within the range of cleared devices—red/infrared mode matches K221775 exactly, and blue mode is comparable to K241857 (10 vs. 18 mW/cm²). Component materials are identical to previously cleared device K202390. All performance testing passed applicable consensus standards with no unexpected results, and the minor differences in intensity do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov