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FDA 510(k)

CAREUS 接觸鏡盒（型號 1、型號 2、型號 3、型號 4、型號 5、型號 6）

K 號：K240095 · 2024-10-09

申請人Shanghai Care US Medical Product Co., Ltd.
決定日期2024-10-09
產品代碼LRX
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

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Care US Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K240095. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is Shanghai Care US Medical Product Co., Ltd.. The 510(k) number is K240095.

When did CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) receive FDA 510(k) clearance?

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) received FDA 510(k) clearance on 2024-10-09, under 510(k) number K240095.

Who is the listed applicant for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

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

What is the FDA product code for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

The FDA product code for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is LRX.

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：LRX）

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。

K252175LANDR 接觸鏡盒Fourth Axis, LLCK250495MINI VP1 (PL67_F)；MINI VP1 (PL61_F)Avizor S.A.K231123飛鳳眼鏡盒 - 圓頂平裝盒 (CL-01)；飛鳳眼鏡盒 - 經典平裝盒 (CL-02)；飛鳳眼鏡盒 - 太陽眼鏡形狀平裝盒 (CL-03)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.K173538清潔消毒液 Clear Care，AOCup 鏡盒搭配 AODiscAlcon Laboratories, Inc.K172925隐形眼鏡盒，型號：A-1，B-1P L Overseas LimitedK173365保舒寶波士頓角結膜鏡盒Bausch & Lomb, Incorporated

官方來源

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