FDA 510(k)

Préime DermaFacial (MicroT)

K号: K243072 · 2025-04-01

决定日期2025-04-01

产品代码NFO

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决定实质等同

器械摘要

Préime DermaFacial (MicroT) is the device name listed in this FDA 510(k) record. The listed applicant is EMA Aesthetics , Ltd.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K243072. 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 Préime DermaFacial (MicroT)?

Préime DermaFacial (MicroT) is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is EMA Aesthetics , Ltd.. The 510(k) number is K243072.

When did Préime DermaFacial (MicroT) receive FDA 510(k) clearance?

Préime DermaFacial (MicroT) received FDA 510(k) clearance on 2025-04-01, under 510(k) number K243072.

Who is the listed applicant for Préime DermaFacial (MicroT)?

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

What is the FDA product code for Préime DermaFacial (MicroT)?

The FDA product code for Préime DermaFacial (MicroT) is NFO.

列明EMA Aesthetics , 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。

K243055Préime DermaFacial 胶原蛋白+

官方来源

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