FDA PMA

鏡片、隱形眼鏡、正視矯正術、隔夜

PMA 核准號：P050031 · 2022-05-10

申請人CooperVision, Inc.

決定日期2022-05-10

PMA 編號P050031

產品代碼NUU

器械分類3 類

醫療專科O

法規編號21 CFR 8

諮詢委員會此為醫療器材法規文本之翻譯。根據醫療法規翻譯政策，以下為繁體中文譯文：本文件概述適用於醫療器材之監管架構，包括美國食品藥物管理局（FDA）之上市前審查程序。第510(k)條途徑適用於與已合法上市器材（predicate device）實質等效之器材，而上市前核准（PMA）則為最高風險等級（Class III）器材所要求。臨床證據可能引用NCT編號之試驗登記，或PMID編號之同行評審文獻。所有產品名稱、公司名稱、識別碼及統一資源定位符（URL）均保留原文，以確保可追溯性及法規提交之完整性。

器材摘要

Lens, contact, orthokeratology, overnight is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 2022-05-10. The device is classified under product code NUU. It was reviewed by the OP advisory panel.

常見問題

What is the Lens, contact, orthokeratology, overnight?

Lens, contact, orthokeratology, overnight is a medical device that received FDA 510(k) clearance on 2022-05-10. The listed applicant is CooperVision, Inc..

When did Lens, contact, orthokeratology, overnight receive FDA 510(k) clearance?

The clearance date for Lens, contact, orthokeratology, overnight can be found in the official FDA records.

誰是列出的Lens、contact、orthokeratology、overnight申請人？

The FDA 510(k) record lists CooperVision, Inc. as the applicant. This does not by itself establish the device manufacturer.

什麼是FDA眼鏡、隐形眼鏡、正視療法、夜間使用的產品編號？

FDA產品代碼，對於鏡片、隱形眼鏡、正視療法、夜間佩戴的產品為NUU。

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

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官方來源