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FDA 510(k)

InMode系统带Morpheus8 (Fractora)探头

K号: K192695 · 2019-12-27

申请人Inmode MD , Ltd.
决定日期2019-12-27
产品代码GEI
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

InMode System with the Morpheus8 (Fractora) Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192695. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InMode System with the Morpheus8 (Fractora) Applicators?

InMode System with the Morpheus8 (Fractora) Applicators is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K192695.

When did InMode System with the Morpheus8 (Fractora) Applicators receive FDA 510(k) clearance?

InMode System with the Morpheus8 (Fractora) Applicators received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192695.

Who is the listed applicant for InMode System with the Morpheus8 (Fractora) Applicators?

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

What is the FDA product code for InMode System with the Morpheus8 (Fractora) Applicators?

The FDA product code for InMode System with the Morpheus8 (Fractora) Applicators is GEI.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Inmode MD , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K210492InMode射频Pro系统K191855EmFace DeviceK183450EmBody SystemK182325InMode射频系统K180719InMode Diolaze 系统K180189InMode系统带Fractora3D/3D-90探头

查看所有 16 个设备 →

相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLCK261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker InstrumentsK261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364艾利安谜团射频设备Ellian CorpK253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

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