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FDA 510(k)

Aimanfun Lumea Comfort

K-Number: K190820 · 2019-10-02

ApplicantKam Yuen Plastic Products , Ltd.
Decision Date2019-10-02
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aimanfun Lumea Comfort is a medical device manufactured by Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2019-10-02 under approval number K190820. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aimanfun Lumea Comfort?

Aimanfun Lumea Comfort is a medical device that received FDA 510(k) clearance on 2019-10-02. It is manufactured by Kam Yuen Plastic Products , Ltd.. The 510(k) number is K190820.

When was Aimanfun Lumea Comfort approved by the FDA?

Aimanfun Lumea Comfort received FDA 510(k) clearance on 2019-10-02, under approval number K190820.

What company makes Aimanfun Lumea Comfort?

Aimanfun Lumea Comfort is manufactured by Kam Yuen Plastic Products , Ltd..

What is the FDA product code for Aimanfun Lumea Comfort?

The FDA product code for Aimanfun Lumea Comfort is OHT.

Other Devices by Kam Yuen Plastic Products , Ltd.

K212907Aimanfun Lumea Comfort, A-2789/A-3588 K213027Laser Hair Growth Comb K213025Laser hair growth helmet K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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