LED光疗面罩（A093）
K号: K250880 · 2025-06-20
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决定日期2025-06-20
产品代码OHS
咨询委员会SU
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决定实质等同
器械摘要
LED LIGHT MASK (A093) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Guangyu Weilai Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250880. 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 LED LIGHT MASK (A093)?
LED LIGHT MASK (A093) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Foshan Guangyu Weilai Medical Equipment Co., Ltd.. The 510(k) number is K250880.
When did LED LIGHT MASK (A093) receive FDA 510(k) clearance?
LED LIGHT MASK (A093) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250880.
Who is the listed applicant for LED LIGHT MASK (A093)?
The FDA 510(k) record lists Foshan Guangyu Weilai Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LED LIGHT MASK (A093)?
The FDA product code for LED LIGHT MASK (A093) 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。
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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