FDA 510(k)

LYKOS 辅助生殖雷射儀搭配動態目標導引系統（DTS）

K 號：K202241 · 2021-07-02

決定日期2021-07-02

產品代碼MRX

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K202241. The device is classified under product code MRX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Hamilton Thorne, Inc.. The 510(k) number is K202241.

When did LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) receive FDA 510(k) clearance?

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) received FDA 510(k) clearance on 2021-07-02, under 510(k) number K202241.

Who is the listed applicant for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

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

What is the FDA product code for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

The FDA product code for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is MRX.

其他以 Hamilton Thorne, 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。

K191552GM501 矿物油 K190383GM501清潔器

相關器械（代碼：MRX）

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。

K253333輔助生殖雷射系統（型號ILS-400M）Hua Yue Medical Technology Co., Ltd.K192008雷射射擊M，導航雷射Vitrolife GmbH

官方來源

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