FDA 510(k)

LED Light Therapy Device, KN-7000L

N.º K: K222751 · 2023-02-01

SolicitanteXuzhou Kernel Medical Equipment Co., Ltd.

Fecha de decisión2023-02-01

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Device, KN-7000L is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K222751. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LED Light Therapy Device, KN-7000L?

LED Light Therapy Device, KN-7000L is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K222751.

When did LED Light Therapy Device, KN-7000L receive FDA 510(k) clearance?

LED Light Therapy Device, KN-7000L received FDA 510(k) clearance on 2023-02-01, under 510(k) number K222751.

Who is the listed applicant for LED Light Therapy Device, KN-7000L?

The FDA 510(k) record lists Xuzhou Kernel Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Device, KN-7000L?

The FDA product code for LED Light Therapy Device, KN-7000L is GEX. This falls under the Gastroenterology category.

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 Xuzhou Kernel Medical Equipment Co., Ltd. como solicitante

K261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)K242977Dispositivo de fototerapia de excímero de 308 nm (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)K200971Sistema Excimer de 308nm K200929Hair Growth System K190685Hair Growth System K181805UV Phototherapy

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., 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.