FDA 510(k)

Luminance 红色疱疹设备 (TN1927G)

K号: K251973 · 2025-09-23

决定日期2025-09-23

产品代码OKJ

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决定实质等同

器械摘要

Luminance Red Cold Sore Device (TN1927G) is the device name listed in this FDA 510(k) record. The listed applicant is Luminance Medical Ventures, Inc.. It received FDA 510(k) clearance on 2025-09-23 under 510(k) number K251973. The device is classified under product code OKJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Luminance Red Cold Sore Device (TN1927G)?

Luminance Red Cold Sore Device (TN1927G) is a medical device that received FDA 510(k) clearance on 2025-09-23. The listed applicant is Luminance Medical Ventures, Inc.. The 510(k) number is K251973.

When did Luminance Red Cold Sore Device (TN1927G) receive FDA 510(k) clearance?

Luminance Red Cold Sore Device (TN1927G) received FDA 510(k) clearance on 2025-09-23, under 510(k) number K251973.

Who is the listed applicant for Luminance Red Cold Sore Device (TN1927G)?

The FDA 510(k) record lists Luminance Medical Ventures, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luminance Red Cold Sore Device (TN1927G)?

The FDA product code for Luminance Red Cold Sore Device (TN1927G) is OKJ.

列明Luminance Medical Ventures, Inc.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。

K220729The Luminance RED Acne Device

官方来源

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