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FDA 510(k)

IPL hair removal machine

K-Number: K213020 · 2021-12-16

ApplicantShenzhen Borria Technology Co., Ltd.
Decision Date2021-12-16
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL hair removal machine is a medical device manufactured by Shenzhen Borria Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-16 under approval number K213020. 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 IPL hair removal machine?

IPL hair removal machine is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Shenzhen Borria Technology Co., Ltd.. The 510(k) number is K213020.

When was IPL hair removal machine approved by the FDA?

IPL hair removal machine received FDA 510(k) clearance on 2021-12-16, under approval number K213020.

What company makes IPL hair removal machine?

IPL hair removal machine is manufactured by Shenzhen Borria Technology Co., Ltd..

What is the FDA product code for IPL hair removal machine?

The FDA product code for IPL hair removal machine is OHT.

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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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