FDA 510(k)

ALLY自適應白內障治療系統

K 號：K220259 · 2022-06-09

決定日期2022-06-09

產品代碼OOE

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

ALLY Adaptive Cataract Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Lensar, Inc.. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K220259. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ALLY Adaptive Cataract Treatment System?

ALLY Adaptive Cataract Treatment System is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Lensar, Inc.. The 510(k) number is K220259.

When did ALLY Adaptive Cataract Treatment System receive FDA 510(k) clearance?

ALLY Adaptive Cataract Treatment System received FDA 510(k) clearance on 2022-06-09, under 510(k) number K220259.

Who is the listed applicant for ALLY Adaptive Cataract Treatment System?

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

What is the FDA product code for ALLY Adaptive Cataract Treatment System?

The FDA product code for ALLY Adaptive Cataract Treatment System is OOE.

其他以 Lensar, 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。

K182795LENSAR 激光系統 - fs 3D (LLS-fs 3D)K181430LENSAR 激光系統 - fs 3D (LLS-fs 3D)K173346LENSAR 激光系統 - fs 3D (LLS-fs 3D)K171337LENSAR 激光系統 – fs 3D (LLS-fs 3D)K170576LENSAR 激光系統 - fs 3D (LLS-fs 3D)

相關器械（代碼：OOE）

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。

K252682LenSx 激光系統 (8065000944)Alcon Laboratories, Inc.K243896LenSx 激光系統 (8065998162)Alcon Laboratories, Inc.K223566ELITA™ 飛秒雷射系統，ELITA™ 病患介面Johnson & Johnson Surgical Vision, Inc.K223838Catalys™精準雷射系統Amo Manufacturing USA, LLC K220516CATALYS精準雷射系統Amo Manufacturing USA, LLC K213559FEMTO LDV Z8 飛秒手術雷射Sie Ag,Surgical Instrument Engineering

官方來源

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