Shenzhen Kaiyan Medical Equipment Co., Ltd. · Class II · Cleared Feb 14, 2025
| K-number | K242593 |
| Device name | CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) |
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Product code | OHS |
| Device class | Class II |
| Decision date | Feb 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The CurrentBody LED 4 in 1 Zone Facial Mapping Mask is a wearable light-emitting diode phototherapy device for at-home use. It treats mild to moderate acne vulgaris and full-face wrinkles using multiple LED light wavelengths (blue, red, yellow, and infrared). Four models target different indications: MK-90C treats acne and wrinkles, MK-90M treats wrinkles only, MK66RB-F treats acne only, and MK-90N treats periorbital wrinkles.
The subject device emits multiple wavelength combinations: MK-90C offers red+infrared, blue+red, and yellow+infrared modes; MK-90M and MK-90N use red+infrared and yellow+infrared respectively; MK66RB-F uses red+blue. Power densities range from 10–25 mW/cm² across wavelengths. Treatment duration is 10 minutes per session. The device is powered by rechargeable lithium batteries (either 5200 mAh or 2600 mAh depending on model) and controlled via software timer.
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (general medical device safety); IEC 60601-1-2:2014+AMD1:2020 (electromagnetic compatibility); IEC 60601-1-11:2015+AMD1:2020 (home healthcare environment); IEC 60601-2-57:2023 (non-laser light source equipment); IEC 62471:2006 (photobiological safety); ISO 10993-5, 10993-10, and 10993-23 (biocompatibility testing for cytotoxicity, sensitization, and skin irritation).
The subject device shares the same product code (OHS, OLP), regulation number (21 CFR 878.4810), FDA classification (Class II), and over-the-counter use as predicate devices K214103 and K240089. Although wavelengths and power densities differ slightly, the predicate devices' ±10 nm tolerance ranges encompass the subject device's specifications. The subject device's lower power density for yellow+infrared mode (25 mW/cm²) compared to the predicate (35 mW/cm²) does not raise safety concerns. All devices use identical LED technology, uniform distribution, 10-minute treatment protocols, and comply with the same electrical safety and photobiological standards, demonstrating equivalent safety and effectiveness.
View the full FDA submission: accessdata.fda.gov