FDA 510(k)

LENSAR 激光系統 - fs 3D (LLS-fs 3D)

K 號：K181430 · 2018-08-09

決定日期2018-08-09

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

LENSAR Laser System - fs 3D (LLS-fs 3D) is the device name listed in this FDA 510(k) record. The listed applicant is Lensar, Inc.. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K181430. 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 LENSAR Laser System - fs 3D (LLS-fs 3D)?

LENSAR Laser System - fs 3D (LLS-fs 3D) is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Lensar, Inc.. The 510(k) number is K181430.

When did LENSAR Laser System - fs 3D (LLS-fs 3D) receive FDA 510(k) clearance?

LENSAR Laser System - fs 3D (LLS-fs 3D) received FDA 510(k) clearance on 2018-08-09, under 510(k) number K181430.

Who is the listed applicant for LENSAR Laser System - fs 3D (LLS-fs 3D)?

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 LENSAR Laser System - fs 3D (LLS-fs 3D)?

The FDA product code for LENSAR Laser System - fs 3D (LLS-fs 3D) 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。

K220259ALLY自適應白內障治療系統 K182795LENSAR 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 K220259ALLY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

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