FDA 510(k)

AcuPulse (anteriormente llamado AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO

N.º K: K180597 · 2018-04-03

Fecha de decisión2018-04-03

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K180597. 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 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Lumenis, Ltd.. The 510(k) number is K180597.

When did AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO receive FDA 510(k) clearance?

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO received FDA 510(k) clearance on 2018-04-03, under 510(k) number K180597.

Who is the listed applicant for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

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

What is the FDA product code for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

The FDA product code for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO 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 Lumenis, Ltd. como solicitante

K212703Sistema de Laser CO2 AcuPulse, Dispositivos de Entrega y Accesorios K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories K202428Sistemas de Laser CO2 AcuPulse W, Dispositivos de Entrega y Accesorios K201663Sistemas de Laser CO2 AcuPulse W, Dispositivos de Entrega y Accesorios K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser System K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

Ver todos los 10 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.