FEMTO LDV Z8 飛秒手術雷射
K 號：K213559 · 2022-04-21
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決定日期2022-04-21
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
FEMTO LDV Z8 Femtosecond Surgical Laser is the device name listed in this FDA 510(k) record. The listed applicant is Sie Ag,Surgical Instrument Engineering. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213559. 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 FEMTO LDV Z8 Femtosecond Surgical Laser?
FEMTO LDV Z8 Femtosecond Surgical Laser is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Sie Ag,Surgical Instrument Engineering. The 510(k) number is K213559.
When did FEMTO LDV Z8 Femtosecond Surgical Laser receive FDA 510(k) clearance?
FEMTO LDV Z8 Femtosecond Surgical Laser received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213559.
Who is the listed applicant for FEMTO LDV Z8 Femtosecond Surgical Laser?
The FDA 510(k) record lists Sie Ag,Surgical Instrument Engineering as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser?
The FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser is OOE.
相關臨床試驗
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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, LLCK220259ALLY自適應白內障治療系統Lensar, Inc.K220516CATALYS精準雷射系統Amo Manufacturing USA, LLC
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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