FDA 510(k)

LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)

N.º K: K261601 · 2026-08-07

SolicitanteShenzhen Chuangtong Yigou Technology Co., Ltd.

Fecha de decisión2026-08-07

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Chuangtong Yigou Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261601. 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 Mask (M01, M02, M03, M05, M06, M07, M08)?

LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Shenzhen Chuangtong Yigou Technology Co., Ltd.. The 510(k) number is K261601.

When did LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) receive FDA 510(k) clearance?

LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261601.

Who is the listed applicant for LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)?

The FDA 510(k) record lists Shenzhen Chuangtong Yigou Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)?

The FDA product code for LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Shenzhen Chuangtong Yigou Technology Co., Ltd. como solicitante

K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)

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.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 K2605985 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.