FDA 510(k)

Sistema de Laser de CO2 AcuPulse, Dispositivos de Entrega e Acessórios

Número K: K212703 · 2021-10-19

Data da decisão2021-10-19

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AcuPulse CO2 Laser System, 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 2021-10-19 under 510(k) number K212703. 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.

Perguntas frequentes

What is the AcuPulse CO2 Laser System, Delivery Devices and Accessories?

AcuPulse CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Lumenis, Ltd.. The 510(k) number is K212703.

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

AcuPulse CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2021-10-19, under 510(k) number K212703.

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

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

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Outros registros que listam Lumenis, Ltd. como candidato(a)

K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories K202428Sistemas de Laser de CO2 AcuPulse W, Dispositivos de Entrega e Acessórios K201663Sistemas de Laser de CO2 AcuPulse W, Dispositivos de Entrega e Acessórios K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser System K180597AcuPulse (anteriormente chamado AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

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Fonte oficial

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