FDA 510(k)

Vexillum (olifilcon B) 配合觸感聚合物矽膠軟性隐形眼镜；Daily Breeze (olifilcon B) 矽膠軟性隐形眼镜

K 號：K181349 · 2018-09-19

決定日期2018-09-19

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

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K181349. 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 Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens?

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Visco Vision, Inc.. The 510(k) number is K181349.

When did Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens receive FDA 510(k) clearance?

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens received FDA 510(k) clearance on 2018-09-19, under 510(k) number K181349.

Who is the listed applicant for Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens?

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

What is the FDA product code for Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens?

The FDA product code for Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is LPL.

其他以 Visco Vision, Inc. 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。

K200618HydroSens A (hioxifilcon A) 球形水凝胶軟性隐形眼鏡 K201080每日濃霧B (olifilcon B) 球形矽膠水凝軟性隐形眼镜，每日濃霧B (olifilcon B) 球面矽膠水凝軟性隐形眼镜，每日濃霧B (olifilcon B) 多焦矽膠水凝軟性隐形眼镜 K191397OxySoft (olifilcon C) 硅膠水凝軟性隐形眼镜 K183670Vexillum Zephyr (olifilcon A) 內含實體聚合物球面/橫軸/多焦距矽膠水凝膠軟性隐形眼鏡；OxyPure A (olifilcon A) 球面/橫軸/多焦距矽膠水凝膠軟性隐形眼鏡 K180322Si-Hy（olifilcon B）顏色矽膠水凝軟性隐形眼镜 K173958OxyAqua（olifilcon D）球面矽膠水凝膠軟性隐形眼镜，OxyAqua（olifilcon D）雙焦矽膠水凝膠軟性隐形眼镜，OxyAqua（olifilcon D）散光矽膠水凝膠軟性隐形眼镜

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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。

官方來源

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