FDA 510(k)

Legend X 应用器 VO

K号: K240999 · 2024-05-08

决定日期2024-05-08

产品代码GEI

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决定实质等同

器械摘要

Legend X Applicator VO is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2024-05-08 under 510(k) number K240999. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Legend X Applicator VO?

Legend X Applicator VO is a medical device that received FDA 510(k) clearance on 2024-05-08. The listed applicant is Pollogen, Ltd.. The 510(k) number is K240999.

When did Legend X Applicator VO receive FDA 510(k) clearance?

Legend X Applicator VO received FDA 510(k) clearance on 2024-05-08, under 510(k) number K240999.

Who is the listed applicant for Legend X Applicator VO?

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

What is the FDA product code for Legend X Applicator VO?

The FDA product code for Legend X Applicator VO is GEI.

列明Pollogen, 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。

K242227GENEO X ELITE K252576Legend X 平台 K250734OptiLUV 设备 K243217Legend X 桌面系统 K233766Geneo X Elite K232903Legend X 平台

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相关器械（代码：GEI）

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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