K-number	K250830
Device name	LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
Applicant	Shenzhen Sungrow Led Technology Co., Ltd.
Product code	OHS
Device class	Class II
Decision date	Jun 9, 2025
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The LED Light Therapy Mask is a wearable device that emits different wavelengths of light for dermatological treatment. It is indicated for treatment of full-face wrinkles using red, yellow, or red+infrared light, and for treatment of mild to moderate inflammatory acne using blue light or mixed red+blue+infrared light. The device is available in multiple models and is intended for over-the-counter use.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

Everything you need for a 510(k) submission. Nothing you don't.