FDA 510(k)

Aimanfun Lumea Comfort，型号：A-2788，A-2789和A-3588

K号: K230107 · 2023-04-05

决定日期2023-04-05

产品代码OHT

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决定实质等同

器械摘要

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K230107. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588?

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K230107.

When did Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 receive FDA 510(k) clearance?

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 received FDA 510(k) clearance on 2023-04-05, under 510(k) number K230107.

Who is the listed applicant for Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588?

FDA 510(k)记录将嘉源塑料制品有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588?

The FDA product code for Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is OHT.

列明Kam Yuen Plastic Products , 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。

K260767面部美容设备（面部面膜LED美容设备A-901；面部LED & EMS美容设备A-902；面部面膜LED & EMS美容设备A-907）K213027激光生发梳 K213025激光生发头盔 K212907Aimanfun Lumea Comfort, A-2789/A-3588 K190820Aimanfun Lumea Comfort

相关器械（代码：OHT）

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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