FDA.report

510(k) K251254

Device
Ignite RF System
Applicant
InMode , Ltd.
510(k) number
K251254
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-15
Date received
2025-04-23
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Suhair Francis
Address
Tabor Bldg., Shaar Yokneam Pob 44 Yokneam Illit IL 2069200 2069200

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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