FDA 510(k)

Lotus III多脉冲Er: Yag激光系统

K号: K182045 · 2018-12-27

决定日期2018-12-27

产品代码GEX

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决定实质等同

器械摘要

Lotus III Multi-Pulsed Er: Yag Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2018-12-27 under 510(k) number K182045. 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 Lotus III Multi-Pulsed Er: Yag Laser System?

Lotus III Multi-Pulsed Er: Yag Laser System is a medical device that received FDA 510(k) clearance on 2018-12-27. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K182045.

When did Lotus III Multi-Pulsed Er: Yag Laser System receive FDA 510(k) clearance?

Lotus III Multi-Pulsed Er: Yag Laser System received FDA 510(k) clearance on 2018-12-27, under 510(k) number K182045.

Who is the listed applicant for Lotus III Multi-Pulsed Er: Yag Laser System?

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

What is the FDA product code for Lotus III Multi-Pulsed Er: Yag Laser System?

The FDA product code for Lotus III Multi-Pulsed Er: Yag Laser System is GEX. This falls under the Gastroenterology category.

列明Laseroptek Co., 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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