FDA 510(k)

ICOONE雷射醫療設備（亦稱為ICOONE醫療雷射）

K 號：K211272 · 2021-06-22

決定日期2021-06-22

產品代碼NUV

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 I-Tech Industries Srl 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K182453ICOONE h（也稱為ICOONE LASER及ICOONE –h LASER）

相關器械（代碼：NUV）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261582真空輪RF瘦身設備（醫用）（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（也稱為ICOONE LASER及ICOONE –h LASER）I-Tech Industries Srl K161892瘦身治療設備Beijing Honkon Technologies Co., Ltd.

官方來源

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