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FDA 510(k)

ICOONE Laser Med (also referred to as ICOONE Medical laser)

N.º K: K211272 · 2021-06-22

SolicitanteI-Tech Industries Srl
Fecha de decisión2021-06-22
Código de productoNUV
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

ICOONE Laser Med (also referred to as ICOONE Medical laser) is the device name listed in this FDA 510(k) record. The listed applicant is I-Tech Industries Srl. It received FDA 510(k) clearance on 2021-06-22 under 510(k) number K211272. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ICOONE Laser Med (also referred to as ICOONE Medical laser)?

ICOONE Laser Med (also referred to as ICOONE Medical laser) is a medical device that received FDA 510(k) clearance on 2021-06-22. The listed applicant is I-Tech Industries Srl. The 510(k) number is K211272.

When did ICOONE Laser Med (also referred to as ICOONE Medical laser) receive FDA 510(k) clearance?

ICOONE Laser Med (also referred to as ICOONE Medical laser) received FDA 510(k) clearance on 2021-06-22, under 510(k) number K211272.

Who is the listed applicant for ICOONE Laser Med (also referred to as ICOONE Medical laser)?

The FDA 510(k) record lists I-Tech Industries Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICOONE Laser Med (also referred to as ICOONE Medical laser)?

The FDA product code for ICOONE Laser Med (also referred to as ICOONE Medical laser) is NUV.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Otros registros que enlistan a I-Tech Industries Srl como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

Dispositivos relacionados (Código: NUV)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K231092T-SHAPE 2B&M S.R.L. Marketing Nel BenessereK182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries SrlK161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.

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.

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