FDA 510(k)

Sistemas de Laser CO2 AcuPulse W, Dispositivos de Entrega y Accesorios

N.º K: K202428 · 2020-10-22

Fecha de decisión2020-10-22

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2020-10-22 under 510(k) number K202428. 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 W CO2 Laser Systems, Delivery Devices and Accessories?

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2020-10-22. The listed applicant is Lumenis, Ltd.. The 510(k) number is K202428.

When did AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories receive FDA 510(k) clearance?

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories received FDA 510(k) clearance on 2020-10-22, under 510(k) number K202428.

Who is the listed applicant for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories?

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 W CO2 Laser Systems, Delivery Devices and Accessories?

The FDA product code for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

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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 K201663Sistemas de Laser CO2 AcuPulse W, Dispositivos de Entrega y Accesorios K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser System K180597AcuPulse (anteriormente llamado AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

Ver todos los 10 dispositivos →

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Fuente oficial

Ver en la base de datos de la FDA →

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