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K250830 FDA 510(k) Clearance: Named LED Mask Models, Family-Level Indications, and Verification

G15 red light therapy mask — product image

Short answer: The FDA’s public record identifies K250830 as a Traditional 510(k) for an LED Light Therapy Mask, submitted by Shenzhen Sungrow LED Technology Co., Ltd. FDA issued a substantially equivalent decision on June 9, 2025. The record names 13 model designations and lists family-level OTC light-mode and indication statements for full-face wrinkles or mild-to-moderate inflammatory acne. […]

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