myLEDmask 2（MJ-144）
K号: K260415 · 2026-05-12
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决定日期2026-05-12
产品代码OHS
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
myLEDmask 2 (MJ-144) 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 2026-05-12 under 510(k) number K260415. 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 myLEDmask 2 (MJ-144)?
myLEDmask 2 (MJ-144) is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K260415.
When did myLEDmask 2 (MJ-144) receive FDA 510(k) clearance?
myLEDmask 2 (MJ-144) received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260415.
Who is the listed applicant for myLEDmask 2 (MJ-144)?
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 myLEDmask 2 (MJ-144)?
The FDA product code for myLEDmask 2 (MJ-144) is OHS.
相关临床试验
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。
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。
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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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。
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