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FDA 510(k)

Ignite RF System

K-Number: K251254 · 2026-01-15

ApplicantInMode , Ltd.
Decision Date2026-01-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing InMode , Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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