Shenzhen Siken 3D Technology Development Co., Ltd. · Class II · Cleared Dec 23, 2025
| K-number | K252146 |
| Device name | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) |
| Applicant | Shenzhen Siken 3D Technology Development Co., Ltd. |
| Product code | NFO |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.5890 |
The Multi-functional Facial Beauty Device is a handheld, portable, over-the-counter aesthetic device for facial stimulation using micro-current mode. It includes additional non-regulated features such as red and blue LED light, hot compress, and vibration functions, and is powered by an internal rechargeable lithium battery.
The device operates with regulated current output, pulse-symmetric biphasic rectangular waveforms at 1.6 kHz frequency, maximum output of 32mA@500Ω and 16Vpp@500Ω, 4μs pulse width, Type BF electrical protection, microprocessor control with automatic shutoff, and a 10-minute timer. It shares the same classification (Class II), product code (NFO), and over-the-counter intended use as predicate devices.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 (nerve and muscle stimulators), IEC 62133-2 (lithium battery safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation).
View the full FDA submission: accessdata.fda.gov