FDA 510(k)

LED Light Therapy Masks (LumiLips FAC07NA)

N.º K: K260202 · 2026-03-23

SolicitanteGuangdong Newdermo Biotech Co., Ltd.

Fecha de decisión2026-03-23

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Masks (LumiLips FAC07NA) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-03-23 under 510(k) number K260202. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LED Light Therapy Masks (LumiLips FAC07NA)?

LED Light Therapy Masks (LumiLips FAC07NA) is a medical device that received FDA 510(k) clearance on 2026-03-23. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K260202.

When did LED Light Therapy Masks (LumiLips FAC07NA) receive FDA 510(k) clearance?

LED Light Therapy Masks (LumiLips FAC07NA) received FDA 510(k) clearance on 2026-03-23, under 510(k) number K260202.

Who is the listed applicant for LED Light Therapy Masks (LumiLips FAC07NA)?

The FDA 510(k) record lists Guangdong Newdermo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Masks (LumiLips FAC07NA)?

The FDA product code for LED Light Therapy Masks (LumiLips FAC07NA) is OHS.

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Otros registros que enlistan a Guangdong Newdermo Biotech Co., Ltd. como solicitante

K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)K260946Máscara de Terapia con Luz LED (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)K223544LED light therapy mask (FM-01, FM-02, FM-03)

Dispositivos relacionados (Código: OHS)

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Fuente oficial

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