免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

ClearColor 1天（hioxifilcon A）每日一次性軟性（親水性）隐形眼镜，Aryan Color 1天（hioxifilcon A）每日一次性軟性（親水性）隐形眼镜

K 號：K192129 · 2019-09-27

申請人Clearlab SG Pte, Ltd.
決定日期2019-09-27
產品代碼LPL
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。
決定相當於

器材摘要

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Clearlab SG Pte, Ltd.. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K192129. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens?

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Clearlab SG Pte, Ltd.. The 510(k) number is K192129.

When did ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens receive FDA 510(k) clearance?

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2019-09-27, under 510(k) number K192129.

Who is the listed applicant for ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens?

The FDA 510(k) record lists Clearlab SG Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens?

The FDA product code for ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is LPL.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：LPL）

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。

K262495美如1日上昇（米法立酮A）Menicon Co, Ltd.K260507Interojo 45（inofilcon A）柔軟（親水）矽膠水凝片鏡，搭配GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) 每日抛弃式柔軟（親水）隱形眼鏡；Pegavision (Polymacon) 柔軟（親水）隱形眼鏡；Pegavision (Polymacon) 彩色每日抛弃式柔軟（親水）隱形眼鏡；Pegavision (Polymacon) 彩色柔軟（親水）隱形眼鏡Pegavision CorporationK261299Pegavision (Toufilcon B) 每日抛弃式柔軟（親水）隱形眼鏡；Pegavision (Toufilcon B) 柔軟（親水）隱形眼鏡Pegavision CorporationK253885PUSCON 水平衡-1日顏色調節 (omafilcon A) 轟軟 (親水) 接觸鏡片；PUSCON 水平衡-1日顏色 (omafilcon A) 轟軟 (親水) 接觸鏡片GEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) 可見度著色軟性（親水）隱形眼鏡；Saview SH Optic 38 UV 球面（Senofilcon A）可見度著色軟性（親水）隱形眼鏡；Saview SH Optic 38 UV 多焦距（Senofilcon A）可見度著色軟性（親水）隱形眼鏡St. shine Optical Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

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。

↑