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FDA 510(k)

拉格蘭DB / DB Color（ocufilcon D）每日佩戴軟性（親水）隱形眼鏡，拉格蘭DB / DB Color（ocufilcon D）每日佩戴軟性（親水）隱形眼鏡用於散光，拉格蘭DB / DB Color（ocufilcon D）每日佩戴軟性（親水）隱形眼鏡用於老花

K 號：K202129 · 2021-04-01

申請人Largan Medical Co., Ltd.
決定日期2021-04-01
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

Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo is the device name listed in this FDA 510(k) record. The listed applicant is Largan Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K202129. 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 Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo?

Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Largan Medical Co., Ltd.. The 510(k) number is K202129.

When did Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo receive FDA 510(k) clearance?

Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo received FDA 510(k) clearance on 2021-04-01, under 510(k) number K202129.

Who is the listed applicant for Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo?

The FDA 510(k) record lists Largan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo?

The FDA product code for Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo 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。

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其他以 Largan Medical Co., Ltd. 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。

K242916拉格蘭U38顏色（波利美康）每日佩戴軟性（親水）隐形眼鏡K233501“拉根健康 AI-Tech”睡眠呼吸中止症及睡眠品質檢查系統（ST-SLP03A）K182674拉格蘭U38（波利瑪康）每日佩戴軟性（親水）隱形眼鏡，拉格蘭U38（波利瑪康）每日佩戴軟性（親水）隱形眼鏡用於散光，拉格蘭U38（波利瑪康）每日佩戴軟性（親水）隱形眼鏡用於老花眼K182523拉格蘭55紫外線顏色（Ocufilcon D）每日佩戴軟性（親水）隐形眼鏡K181232拉格蘭55 UV（ocufilcon D）每日佩戴軟性（親水）隱形眼鏡，拉格蘭55 UV（ocufilcon D）每日佩戴軟性（親水）隱形眼鏡用於散光，拉格蘭55 UV（ocufilcon D）每日佩戴軟性（親水）隱形眼鏡用於老花K181230拉根55（甲基丙烯酸甲酯）每日佩戴軟性（親水）隱形眼鏡，拉根55（甲基丙烯酸甲酯）每日佩戴軟性（親水）隱形眼鏡用於散光，拉根55（甲基丙烯酸甲酯）每日佩戴軟性（親水）隱形眼鏡用於老花眼

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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.

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