K-number	K252142
Device name	Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
Applicant	Shenzhen Siken 3D Technology Development Co., Ltd.
Product code	OHS
Device class	Class II
Decision date	Dec 5, 2025
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Multi-functional Facial Beauty Device is a portable, rechargeable, handheld device for home use that combines LED light therapy (red and blue light), micro-current stimulation, vibration, and heating functions. Depending on the model, blue light treats mild to moderate inflammatory acne, and red light treats facial wrinkles.

Technological characteristics

The device uses LEDs emitting red light at 630nm±10nm (2.3mW/cm²) and blue light at 460nm±10nm (1.33mW/cm²), similar to predicate devices. It includes micro-current stimulation, motor vibration, and heating capabilities (35.5–38.5°C±0.5°C). All modes operate independently, and the device is supplied by an internal rechargeable lithium battery.

Test standards cited

Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation). Electrical safety and EMC: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62133-2. Eye safety: IEC 62471:2006. Software: verification and validation per basic documentation.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

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