FDA 510(k)

LUMA LED 补贴（LUMA 痘痕（TN2197）和LUMA Revive（TN2189））

K号: K231555 · 2023-07-27

决定日期2023-07-27

产品代码OHS

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决定实质等同

器械摘要

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is the device name listed in this FDA 510(k) record. The listed applicant is iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K231555. 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 LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is iSMART Developments, Ltd.. The 510(k) number is K231555.

When did LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) receive FDA 510(k) clearance?

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231555.

Who is the listed applicant for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?

FDA 510(k)记录将iSMART Developments, Ltd.列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?

The FDA product code for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is OHS.

列明iSMART Developments, 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。

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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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官方来源

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