FDA 510(k)

LED光疗设备（SG-FSM，SG-NK，SG-CT）

K号: K253073 · 2025-11-19

决定日期2025-11-19

产品代码OHS

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决定实质等同

器械摘要

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) is the device name listed in this FDA 510(k) record. The listed applicant is Sunglor Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K253073. 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 Device (SG-FSM, SG-NK, SG-CT)?

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Sunglor Technology Co., Ltd.. The 510(k) number is K253073.

When did LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) receive FDA 510(k) clearance?

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) received FDA 510(k) clearance on 2025-11-19, under 510(k) number K253073.

Who is the listed applicant for LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)?

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

What is the FDA product code for LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)?

The FDA product code for LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) is OHS.

列明Sunglor Technology 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。

K253086LED光疗设备（型号：SG-FM，SG-FE）

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

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