FDA 510(k)

Ignite RF System

K号: K251254 · 2026-01-15

决定日期2026-01-15

产品代码GEI

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决定实质等同

器械摘要

Ignite RF System is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K251254. 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 Ignite RF System?

Ignite RF System is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is InMode , Ltd.. The 510(k) number is K251254.

When did Ignite RF System receive FDA 510(k) clearance?

Ignite RF System received FDA 510(k) clearance on 2026-01-15, under 510(k) number K251254.

Who is the listed applicant for Ignite RF System?

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 Ignite RF System?

The FDA product code for Ignite RF System 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。

K251632Optimas MAX系统 K242598DEFINE 系统 (AG612444A)K240780InMode射频系统 K240017InMode系统带Morpheus8 90探头 K233642InMode射频系统 K231495Evolve系统带Transform应用器

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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.

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