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FDA 510(k)

IPL Hair Removal Device (Model: KCA423)

K-Number: K210119 · 2021-05-21

ApplicantShenzhen Boyuan Intelligent Electronic Technology Co., Ltd.
Decision Date2021-05-21
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (Model: KCA423) is a medical device manufactured by Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-05-21 under approval number K210119. 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 IPL Hair Removal Device (Model: KCA423)?

IPL Hair Removal Device (Model: KCA423) is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.. The 510(k) number is K210119.

When was IPL Hair Removal Device (Model: KCA423) approved by the FDA?

IPL Hair Removal Device (Model: KCA423) received FDA 510(k) clearance on 2021-05-21, under approval number K210119.

What company makes IPL Hair Removal Device (Model: KCA423)?

IPL Hair Removal Device (Model: KCA423) is manufactured by Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd..

What is the FDA product code for IPL Hair Removal Device (Model: KCA423)?

The FDA product code for IPL Hair Removal Device (Model: KCA423) is ONF.

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Related PubMed Literature

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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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