FDA 510(k)

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

Número K: K211272 · 2021-06-22

Data da decisão2021-06-22

Código do produtoNUV

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Outros registros que listam I-Tech Industries Srl como candidato(a)

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

Dispositivos Relacionados (Código: NUV)

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 Benessere K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.

Fonte oficial

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