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FDA 510(k)

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

Número K: K231215 · 2023-06-26

RequerenteZhongshan Qizhe Technology Co., Ltd.
Data da decisão2023-06-26
Código do produtoOHT
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Qizhe Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K231215. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Zhongshan Qizhe Technology Co., Ltd.. The 510(k) number is K231215.

When did IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S receive FDA 510(k) clearance?

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 510(k) number K231215.

Who is the listed applicant for IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S?

The FDA 510(k) record lists Zhongshan Qizhe Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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