FDA 510(k)

ICOONE h（也称为ICOONE LASER和ICOONE –h LASER）

K号: K182453 · 2019-01-11

决定日期2019-01-11

产品代码NUV

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决定实质等同

器械摘要

ICOONE h (also referred to as ICOONE LASER and ICOONE –h 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 2019-01-11 under 510(k) number K182453. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)?

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is I-Tech Industries Srl. The 510(k) number is K182453.

When did ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) receive FDA 510(k) clearance?

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182453.

Who is the listed applicant for ICOONE h (also referred to as ICOONE LASER and ICOONE –h 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 h (also referred to as ICOONE LASER and ICOONE –h LASER)?

The FDA product code for ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) is NUV.

列明I-Tech Industries Srl为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K211272ICOONE 激光医疗（也称为ICOONE 医疗激光）

官方来源

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