FDA 510(k)

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories

Número K: K233301 · 2023-12-01

Data da decisão2023-12-01

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K233301. 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 ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories?

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K233301.

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

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2023-12-01, under 510(k) number K233301.

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

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

What is the FDA product code for ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories?

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

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Fonte oficial

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