FDA 510(k)

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

N.º K: K240611 · 2024-06-20

SolicitanteIvylaser (Beijing) Technology Co.,Ltd

Fecha de decisión2024-06-20

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Ivylaser (Beijing) Technology Co.,Ltd como solicitante

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

Dispositivos relacionados (Código: GEX)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.