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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 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 2019-10-02 under 510(k) 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. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K190820.

When did Aimanfun Lumea Comfort receive FDA 510(k) clearance?

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

Who is the listed applicant for Aimanfun Lumea Comfort?

The FDA 510(k) record lists Kam Yuen Plastic Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aimanfun Lumea Comfort?

The FDA product code for Aimanfun Lumea Comfort is OHT.

Other records listing Kam Yuen Plastic Products , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588K213027Laser Hair Growth CombK213025Laser hair growth helmetK212907Aimanfun Lumea Comfort, A-2789/A-3588

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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