FDA 510(k)

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)

N.º K: K261052 · 2026-06-29

SolicitanteGuangdong Newdermo Biotech Co., Ltd.

Fecha de decisión2026-06-29

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) 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 2026-06-29 under 510(k) number K261052. 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 (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)?

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K261052.

When did LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) receive FDA 510(k) clearance?

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) received FDA 510(k) clearance on 2026-06-29, under 510(k) number K261052.

Who is the listed applicant for LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)?

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 (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)?

The FDA product code for LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) 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))K260946Máscara de Terapia con Luz LED (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)K260202LED Light Therapy Masks (LumiLips FAC07NA)K223544LED light therapy mask (FM-01, FM-02, FM-03)

Dispositivos relacionados (Código: OHS)

K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC

Fuente oficial

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