FDA 510(k)

Lumenis Y&R 激光系统

K号: K211979 · 2022-06-21

决定日期2022-06-21

产品代码GEX

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决定实质等同

器械摘要

Lumenis Y&R Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2022-06-21 under 510(k) number K211979. 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 Lumenis Y&R Laser System?

Lumenis Y&R Laser System is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Lumenis, Inc.. The 510(k) number is K211979.

When did Lumenis Y&R Laser System receive FDA 510(k) clearance?

Lumenis Y&R Laser System received FDA 510(k) clearance on 2022-06-21, under 510(k) number K211979.

Who is the listed applicant for Lumenis Y&R Laser System?

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

What is the FDA product code for Lumenis Y&R Laser System?

The FDA product code for Lumenis Y&R Laser System is GEX. This falls under the Gastroenterology category.

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Lumenis Y&R 激光系统

器械摘要

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