FDA 510(k)

超脉冲外科与美容CO2激光系统，输送装置和附件

K号: K203544 · 2020-12-24

决定日期2020-12-24

产品代码GEX

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决定实质等同

器械摘要

UltraPulse Surgical and Aesthetic 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 2020-12-24 under 510(k) number K203544. 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 Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Lumenis, Ltd.. The 510(k) number is K203544.

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

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2020-12-24, under 510(k) number K203544.

Who is the listed applicant for UltraPulse Surgical and Aesthetic 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 UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

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

列明Lumenis, 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。

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官方来源

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