FDA 510(k) Clearance Granted: Our LED Light Therapy Mask Is Officially a Class II Medical Device (K250830)
Introduction On June 9, 2025, the U.S. Food and Drug Administration (FDA) issued a 510(k) substantial equivalence determination for our LED Light Therapy Mask under the official clearance number K250830. This clearance covers 13 device models and authorizes their distribution in the United States as a Class II Over-The-Counter (OTC) medical device for two specific indications: full-face wrinkle treatment and mild-to-moderate inflammatory acne treatment. This article […]