FDA 510(k)

ERISE 激光手柄

K号: K202258 · 2021-04-26

决定日期2021-04-26

产品代码GEX

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决定实质等同

器械摘要

ERISE Laser handpiece is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-04-26 under 510(k) number K202258. 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 ERISE Laser handpiece?

ERISE Laser handpiece is a medical device that received FDA 510(k) clearance on 2021-04-26. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K202258.

When did ERISE Laser handpiece receive FDA 510(k) clearance?

ERISE Laser handpiece received FDA 510(k) clearance on 2021-04-26, under 510(k) number K202258.

Who is the listed applicant for ERISE Laser handpiece?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERISE Laser handpiece?

The FDA product code for ERISE Laser handpiece is GEX. This falls under the Gastroenterology category.

列明El.En Electronic Engineering Spa为申报人的其他记录

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