FDA 510(k)

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

Número K: K230739 · 2023-05-26

RequerenteShenzhen Ionka Medical Technology Co., Ltd.

Data da decisão2023-05-26

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ionka Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230739. 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 Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200?

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Shenzhen Ionka Medical Technology Co., Ltd.. The 510(k) number is K230739.

When did Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 receive FDA 510(k) clearance?

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230739.

Who is the listed applicant for Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200?

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

What is the FDA product code for Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200?

The FDA product code for Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 is OHT.

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Outros registros que listam Shenzhen Ionka Medical Technology Co., Ltd. como candidato(a)

K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200

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