FDA 510(k)

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

Номер K: K231215 · 2023-06-26

ЗаявительZhongshan Qizhe Technology Co., Ltd.

Дата решения2023-06-26

Код продуктаOHT

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OHT)

K261977Braun Aura 9 (6042)Cyden Limited K262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.

Официальный источник

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