FDA 510(k)

InMode系统带Morpheus8 90探头

K号: K240017 · 2024-06-13

决定日期2024-06-13

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 90 Applicator is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K240017. 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 90 Applicator?

InMode System with the Morpheus8 90 Applicator is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is InMode , Ltd.. The 510(k) number is K240017.

When did InMode System with the Morpheus8 90 Applicator receive FDA 510(k) clearance?

InMode System with the Morpheus8 90 Applicator received FDA 510(k) clearance on 2024-06-13, under 510(k) number K240017.

Who is the listed applicant for InMode System with the Morpheus8 90 Applicator?

The FDA 510(k) record lists InMode , 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 90 Applicator?

The FDA product code for InMode System with the Morpheus8 90 Applicator is GEI.

列明InMode , 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。

K251254Ignite RF System K251632Optimas MAX系统 K242598DEFINE 系统 (AG612444A)K240780InMode射频系统 K233642InMode射频系统 K231495Evolve系统带Transform应用器

查看所有 15 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, LLC K261959Neptune® 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 Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。