Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)

N.º K: K260767 · 2026-08-31

SolicitanteKam Yuen Plastic Products , Ltd.
Fecha de decisión2026-08-31
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2026-08-31 under 510(k) number K260767. 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 Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)?

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) is a medical device that received FDA 510(k) clearance on 2026-08-31. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K260767.

¿Cuándo recibió el Dispositivo de Belleza Facial (Máscara de Belleza Facial LED A-901; Dispositivo de Belleza Facial LED y EMS A-902; Máscara de Belleza Facial LED y EMS A-907) la aprobación 510(k) de la FDA?

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) received FDA 510(k) clearance on 2026-08-31, under 510(k) number K260767.

Who is the listed applicant for Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)?

The FDA 510(k) record lists Kam Yuen Plastic Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)?

The FDA product code for Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) is OHS.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Kam Yuen Plastic Products , Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K230107Aimanfun Lumea Comfort, Modelo: A-2788, A-2789 y A-3588K213027Laser Hair Growth CombK213025Laser hair growth helmetK212907Aimanfun Lumea Comfort, A-2789/A-3588K190820Aimanfun Lumea Comfort

Dispositivos relacionados (Código: OHS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑