FDA 510(k)

IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

Número K: K240611 · 2024-06-20

RequerenteIvylaser (Beijing) Technology Co.,Ltd

Data da decisão2024-06-20

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240611. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K240611.

When did IVYLASER Diode laser hair removal system (IVY-HR-Alloy) receive FDA 510(k) clearance?

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240611.

Who is the listed applicant for IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

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

What is the FDA product code for IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

The FDA product code for IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Ivylaser (Beijing) Technology Co.,Ltd como candidato(a)

K250206Diode laser system (Night Universe; Predator)K230025IVYLASER Handhold Hair Removal Machine

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Fonte oficial

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