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FDA 510(k)

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP隐形眼镜搭配實體Hydra-PEG；FluoroPerm 60 & Paragon HDS (paflufocon B) RGP隐形眼镜搭配實體Hydra-PEG；FluoroPerm 92 (paflufocon A) RGP隐形眼镜搭配實體Hydra-PEG；FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP隐形眼镜搭配實體Hydra-PEG

K 號：K180172 · 2018-03-16

申請人Paragon Vision Sciences
決定日期2018-03-16
產品代碼HQD
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

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Vision Sciences. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K180172. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG?

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Paragon Vision Sciences. The 510(k) number is K180172.

When did FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG receive FDA 510(k) clearance?

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG received FDA 510(k) clearance on 2018-03-16, under 510(k) number K180172.

Who is the listed applicant for FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG?

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

What is the FDA product code for FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG?

The FDA product code for FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG is HQD.

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：HQD）

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。

K253822GPA（六氟酮A）硬式透气性隐形眼镜Zhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) 和 Acuity 181™ (tisilfocon A) 配 Tangible™ Hydra-PEG® 硬性透气隐形眼镜Acuity Polymers, Inc.K241398SDJMASTERVISION（氟氧非酮A）硬式透氧性隐形眼镜Tianjin Mastervision Technology Co., Ltd.K241571波士頓視界® 專業鏡片Boston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) 硬性透气隐形眼镜; Acuity 100™ (hexafocon A) 硬性透气隐形眼镜; Acuity 200™ 配 Tangible® Hydra-PEG® (fluoroxyfocon A) 硬性透气隐形眼镜; Acuity 100™ 配 Tangible® Hydra-PEG® (hexafocon A) 硬性透气隐形眼镜Acuity Polymers, Inc.K233325遠見光學角結膜隱形眼鏡（roflufocon D、roflufocon E、hexafocon A、hexafocon B、tisilfocon A、fluoroxyfocon A）Visionary Optics, LLC

官方來源

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