K-number	K252603
Device name	HIGHERDOSE Body Sculptor (Model: GS-03)
Applicant	Shenzhen Kaiyan Medical Equipment Co., Ltd.
Product code	OHS
Device class	Class II
Decision date	Jan 28, 2026
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The HIGHERDOSE Body Sculptor (Model GS-03) is a handheld, home-use light-emitting diode (LED) phototherapy device intended for over-the-counter use to improve the appearance of wrinkles. It emits red light (650nm) and near-infrared light (850nm) for cosmetic skin treatment.

Technological characteristics

The device uses LED technology with wavelengths of 650nm±10nm red light and 850nm±10nm near-infrared light, delivering a combined intensity of 40±10 mW/cm². It is powered by a rechargeable lithium battery and includes a timer and software controller for treatment duration and LED intensity management.

Test standards cited

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-2-57:2011, IEC 62471:2006, IEC 62133-2:2017, ISO 10993-5, ISO 10993-10, ISO 10993-23, IEC 62366-1, and IEC 60601-1-6.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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HIGHERDOSE Body Sculptor (Model: GS-03)

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