FDA 510(k)

Préime DermaFacial 胶原蛋白+

K号: K243055 · 2025-04-15

决定日期2025-04-15

产品代码PBX

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决定实质等同

器械摘要

Préime DermaFacial Collagen+ 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 2025-04-15 under 510(k) number K243055. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Préime DermaFacial Collagen+?

Préime DermaFacial Collagen+ is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is EMA Aesthetics , Ltd.. The 510(k) number is K243055.

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

Préime DermaFacial Collagen+ received FDA 510(k) clearance on 2025-04-15, under 510(k) number K243055.

Who is the listed applicant for Préime DermaFacial Collagen+?

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 Collagen+?

The FDA product code for Préime DermaFacial Collagen+ is PBX.

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。

K243072Préime DermaFacial (MicroT)

官方来源

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