FDA 510(k)

NuFACE® FIX+

K号: K240564 · 2024-06-27

决定日期2024-06-27

产品代码NFO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

NuFACE® FIX+ is the device name listed in this FDA 510(k) record. The listed applicant is Carol Cole Company Dba Nuface®. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K240564. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NuFACE® FIX+?

NuFACE® FIX+ is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Carol Cole Company Dba Nuface®. The 510(k) number is K240564.

When did NuFACE® FIX+ receive FDA 510(k) clearance?

NuFACE® FIX+ received FDA 510(k) clearance on 2024-06-27, under 510(k) number K240564.

Who is the listed applicant for NuFACE® FIX+?

The FDA 510(k) record lists Carol Cole Company Dba Nuface® as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NuFACE® FIX+?

The FDA product code for NuFACE® FIX+ is NFO.

列明Carol Cole Company Dba Nuface®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。

K212947Trinity Plus 纹纹减少器 K201906Trinity ELE Plus 及 Trinity ELE Plus Pro K201782NuFace Trinity Plus 设备 K191672NuFACE Mini 设备 K182424NuFACE FIX 皮肤紧致设备 K181008NuFACE Trinity

查看所有 8 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。