FDA 510(k)

Light Based Hair Removal Device GP592

Número K: K230060 · 2023-03-03

Data da decisão2023-03-03

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Light Based Hair Removal Device GP592 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K230060. 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 Light Based Hair Removal Device GP592?

Light Based Hair Removal Device GP592 is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K230060.

When did Light Based Hair Removal Device GP592 receive FDA 510(k) clearance?

Light Based Hair Removal Device GP592 received FDA 510(k) clearance on 2023-03-03, under 510(k) number K230060.

Who is the listed applicant for Light Based Hair Removal Device GP592?

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

What is the FDA product code for Light Based Hair Removal Device GP592?

The FDA product code for Light Based Hair Removal Device GP592 is OHT.

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Outros registros que listam Shenzhen Gsd Tech Co., Ltd. como candidato(a)

K213225Diode Laser System GP900A8, Diode Laser System GP900Q8 K202827Sistema de Terapia de Luz UV Excimer de 308nm K191518CO2 Laser System K180383Light based hair removal device

Dispositivos Relacionados (Código: 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.

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