LED光疗面罩（FM-01, FM-02, FM-03）
K号: K223544 · 2023-02-23
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决定日期2023-02-23
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 therapy mask (FM-01, FM-02, FM-03) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K223544. 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 therapy mask (FM-01, FM-02, FM-03)?
LED light therapy mask (FM-01, FM-02, FM-03) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K223544.
When did LED light therapy mask (FM-01, FM-02, FM-03) receive FDA 510(k) clearance?
LED light therapy mask (FM-01, FM-02, FM-03) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223544.
Who is the listed applicant for LED light therapy mask (FM-01, FM-02, FM-03)?
FDA 510(k)记录将广东纽德美生物科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for LED light therapy mask (FM-01, FM-02, FM-03)?
The FDA product code for LED light therapy mask (FM-01, FM-02, FM-03) 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Guangdong Newdermo Biotech Co., 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。
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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