LED 光疗床（Pro 450/ GY-680A）
K号: K252786 · 2025-12-01
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决定日期2025-12-01
产品代码OLI
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
Led Light Phototherapy Bed (Pro 450/ GY-680A) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Suyzeko Limited.. It received FDA 510(k) clearance on 2025-12-01 under 510(k) number K252786. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Led Light Phototherapy Bed (Pro 450/ GY-680A)?
Led Light Phototherapy Bed (Pro 450/ GY-680A) is a medical device that received FDA 510(k) clearance on 2025-12-01. The listed applicant is Shenzhen Suyzeko Limited.. The 510(k) number is K252786.
When did Led Light Phototherapy Bed (Pro 450/ GY-680A) receive FDA 510(k) clearance?
Led Light Phototherapy Bed (Pro 450/ GY-680A) received FDA 510(k) clearance on 2025-12-01, under 510(k) number K252786.
Who is the listed applicant for Led Light Phototherapy Bed (Pro 450/ GY-680A)?
The FDA 510(k) record lists Shenzhen Suyzeko Limited. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Led Light Phototherapy Bed (Pro 450/ GY-680A)?
The FDA product code for Led Light Phototherapy Bed (Pro 450/ GY-680A) is OLI.
相关临床试验
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相关器械（代码：OLI）
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
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