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 a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2026-01-15 under approval 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. It is manufactured by InMode , Ltd.. The 510(k) number is K251254.
When was Ignite RF System approved by the FDA?
Ignite RF System received FDA 510(k) clearance on 2026-01-15, under approval number K251254.
What company makes Ignite RF System?
Ignite RF System is manufactured by InMode , Ltd..
What is the FDA product code for Ignite RF System?
The FDA product code for Ignite RF System is GEI.
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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.