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FDA 510(k)

VERITAS 超聲乳化儀控制台，VERITAS 先進流體學組合包和先進輸注組合包，VERITAS 旋轉手柄，VERITAS 先進腳踏板，VERITAS 遙控器

K 號：K203060 · 2021-03-12

申請人Johnson & Johnson Surgical Vision, Inc.
決定日期2021-03-12
產品代碼HQC
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

VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K203060. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control?

VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K203060.

When did VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control receive FDA 510(k) clearance?

VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203060.

Who is the listed applicant for VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control?

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

What is the FDA product code for VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control?

The FDA product code for VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control is HQC.

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

其他以 Johnson & Johnson Surgical 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。

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相關器械（代碼：HQC）

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。

K261264Stellaris Elite™ 视覺增強系統；後置及合併手術包：23 ga. 後置 Elite™ 包（SE5423）；23 ga. Bi-Blade™ 玻璃體切割器後置 Stellaris Elite™ 包（SE5423B）；25 ga. 後置 Elite™ 包（SE5425）；25 ga. Bi-Blade™ 玻璃體切割器後置 Stellaris Elite™ 包（SE5425B）；27 ga. Bi-Blade™ 玻璃體切割器後置 Stellaris Elite™ 包（SE5427B）；23 ga. Bi-Blade™+ 玻璃體切割器後置 Stellaris Elite™ 包（SE5423BB+）；25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ 视覺增強系統（BL11145、BL14455、BL15455、SE14565、SE15565、SE14565E、SE15565E）Bausch and Lomb, IncorporatedK250501系統SophiThis AGK243395MICOR 700 配合自動 I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 系統（N/A）；MICOR 700 驱動器（FG-50631）；MICOR 700 提取器（FG-50621）；MICOR 700 維脈切除器（FG-51185）Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite視覺增強系統（BL11145、BL14455、BL15455）Bausch and Lomb, Incorporated

官方來源

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