FDA 510(k)

ULTRApulse Alpha 二氧化碳激光系统，输送装置和附件

K号: K233301 · 2023-12-01

决定日期2023-12-01

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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?

FDA 510(k)记录将Lumenis Be, Ltd.列为申请人。这本身并不能确立该设备的制造商。

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.

列明Lumenis Be, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241973SmartIPL_NI 系统 K253803MILAN System K250809Stellar M22 K242349FoLix K222790F65 激光系统 K220467UltraPulse CO2 外科和美容激光系列、输送装置和附件

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官方来源

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