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FDA 510(k)

LED治疗灯（COB1400, HP1800PRO）

K号: K253874 · 2026-03-03

申请人Shenzhen Hanhua Opto Co., Ltd.
决定日期2026-03-03
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

LED Therapy Light (COB1400, HP1800PRO) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253874. 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 Therapy Light (COB1400, HP1800PRO)?

LED Therapy Light (COB1400, HP1800PRO) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. The 510(k) number is K253874.

When did LED Therapy Light (COB1400, HP1800PRO) receive FDA 510(k) clearance?

LED Therapy Light (COB1400, HP1800PRO) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253874.

Who is the listed applicant for LED Therapy Light (COB1400, HP1800PRO)?

The FDA 510(k) record lists Shenzhen Hanhua Opto Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Therapy Light (COB1400, HP1800PRO)?

The FDA product code for LED Therapy Light (COB1400, HP1800PRO) is OHS.

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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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