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FDA 510(k)

Saview SH 38 UV (Senofilcon A) 可見度著色軟性（親水）隱形眼鏡；Saview SH 38 UV 球面（Senofilcon A）可見度著色軟性（親水）隱形眼鏡；Saview SH 38 UV 多焦距（Senofilcon A）可見度著色軟性（親水）隱形眼鏡

K 號：K240477 · 2024-07-01

申請人St. shine Optical Co., Ltd.
決定日期2024-07-01
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

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is St. shine Optical Co., Ltd.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K240477. 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 Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens?

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is St. shine Optical Co., Ltd.. The 510(k) number is K240477.

When did Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2024-07-01, under 510(k) number K240477.

Who is the listed applicant for Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens?

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

What is the FDA product code for Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens?

The FDA product code for Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted 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。

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其他以 St. shine Optical 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。

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K250364Saview 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K162317Saview-Colors 水藍 42 UV (Hefilcon A) 轟軟 (親水) 護眼鏡，Saview-Colors 水藍 42 UV 球面 (Hefilcon A) 轟軟 (親水) 護眼鏡，Saview-Colors 水藍 42 UV 多焦距 (Hefilcon A) 轟軟 (親水) 護眼鏡

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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