Объяснение длин волн светодиодной светотерапии: Доказательная база, Одобренный FDA справочник для брендов и практикующих врачей
Light-emitting diode (ВЕЛ) phototherapy has moved from clinical dermatology into mainstream professional beauty and at-home skincare. Yet behind every LED face mask, панель, or handheld device sits a single, decisive engineering choice: Длина волны. The nanometer (н.м.) value printed on a spec sheet is not a marketing number — it determines how deep the light penetrates, which […]
FDA 510(k) Разрешение предоставлено: Наша светодиодная маска для светотерапии официально является медицинским устройством класса II. (K250830)
Introduction On June 9, 2025, США. Управление по контролю за продуктами и лекарствами (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 […]