FDA 510(k)

Bilicocoon™ Phototherapy System

N.º K: K163526 · 2017-10-06

Fecha de decisión2017-10-06

Código de productoLBI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Bilicocoon™ Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Neomedlight. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K163526. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bilicocoon™ Phototherapy System?

Bilicocoon™ Phototherapy System is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Neomedlight. The 510(k) number is K163526.

When did Bilicocoon™ Phototherapy System receive FDA 510(k) clearance?

Bilicocoon™ Phototherapy System received FDA 510(k) clearance on 2017-10-06, under 510(k) number K163526.

Who is the listed applicant for Bilicocoon™ Phototherapy System?

The FDA 510(k) record lists Neomedlight as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bilicocoon™ Phototherapy System?

The FDA product code for Bilicocoon™ Phototherapy System is LBI.

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

Dispositivos relacionados (Código: LBI)

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products K243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited K190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated

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.