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FDA 510(k)

Selecta Duet LED、數位雙聯、Selecta LED 三重奏、數位三聯雷射系統

K 號：K220877 · 2022-07-15

申請人Lumenis Be, Inc.
決定日期2022-07-15
產品代碼HQF
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

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Inc.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K220877. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems?

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Lumenis Be, Inc.. The 510(k) number is K220877.

When did Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems receive FDA 510(k) clearance?

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems received FDA 510(k) clearance on 2022-07-15, under 510(k) number K220877.

Who is the listed applicant for Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems?

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

What is the FDA product code for Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems?

The FDA product code for Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is HQF.

相關臨床試驗

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