FDA 510(k)

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S

K-Number: K231215 · 2023-06-26

ApplicantZhongshan Qizhe Technology Co., Ltd.

Decision Date2023-06-26

Product CodeOHT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is a medical device manufactured by Zhongshan Qizhe Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-26 under approval number K231215. 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 Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S?

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is a medical device that received FDA 510(k) clearance on 2023-06-26. It is manufactured by Zhongshan Qizhe Technology Co., Ltd.. The 510(k) number is K231215.

When was IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S approved by the FDA?

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S received FDA 510(k) clearance on 2023-06-26, under approval number K231215.

What company makes IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S?

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is manufactured by Zhongshan Qizhe Technology Co., Ltd..

What is the FDA product code for IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S?

The FDA product code for IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is OHT.

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Official Source

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