FDA 510(k)

LUSTRE ClearSkin Renew Pro 面部穿戴面膜（型号：PR4001）

K号: K230124 · 2023-03-15

决定日期2023-03-15

产品代码OHS

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决定实质等同

器械摘要

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2023-03-15 under 510(k) number K230124. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K230124.

When did LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) receive FDA 510(k) clearance?

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) received FDA 510(k) clearance on 2023-03-15, under 510(k) number K230124.

Who is the listed applicant for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

The FDA product code for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is OHS.

列明Light Tree Ventures Europe B.V.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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相关器械（代码：OHS）

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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