Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aimanfun Lumea Comfort, A-2789/A-3588

K-Number: K212907 · 2021-12-02

ApplicantKam Yuen Plastic Products , Ltd.
Decision Date2021-12-02
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aimanfun Lumea Comfort, A-2789/A-3588 is a medical device manufactured by Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2021-12-02 under approval number K212907. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aimanfun Lumea Comfort, A-2789/A-3588?

Aimanfun Lumea Comfort, A-2789/A-3588 is a medical device that received FDA 510(k) clearance on 2021-12-02. It is manufactured by Kam Yuen Plastic Products , Ltd.. The 510(k) number is K212907.

When was Aimanfun Lumea Comfort, A-2789/A-3588 approved by the FDA?

Aimanfun Lumea Comfort, A-2789/A-3588 received FDA 510(k) clearance on 2021-12-02, under approval number K212907.

What company makes Aimanfun Lumea Comfort, A-2789/A-3588?

Aimanfun Lumea Comfort, A-2789/A-3588 is manufactured by Kam Yuen Plastic Products , Ltd..

What is the FDA product code for Aimanfun Lumea Comfort, A-2789/A-3588?

The FDA product code for Aimanfun Lumea Comfort, A-2789/A-3588 is ONF.

Other Devices by Kam Yuen Plastic Products , Ltd.

K190820Aimanfun Lumea Comfort K213027Laser Hair Growth Comb K213025Laser hair growth helmet K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

Related Devices (Code: ONF)

K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. K160195Forma System, Forma Light SystemFormatk Systems , Ltd. K153717Venus Versa SystemVenus Concept , Ltd. K152790Venus Versa SystemVenus Concept , Ltd. K181868SHINY RPL SystemIds, Ltd.

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.

↑