Manufacturer
InMode , Ltd.Ignite RF System
Country / Region:Israel (IL)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251254
- Device name
- Ignite RF System
- Company
- InMode , Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-04-23
- Decision date
- 2026-01-15
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The Ignite RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed. Morpheus8: At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Burst and Burst Deep Applicator is limited to Skin Types I-IV.
Intended Use
The Ignite RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.
Device Description
The Ignite RF System is a computerized system generating RF energy for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The Ignite RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpieces are connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available. The System is compatible with the following handpieces: • Monopolar ('RFAL') handpieces: These handpieces are comprised of a disposable, single use plastic handle with active internal electrodes and external (return) electrodes. Both internal and external temperature are constantly monitored. • Bipolar ('Quantum') handpieces: comprised of a disposable, single use plastic handle with active internal bipolar electrodes and no external electrodes. Control of the thermal effect is by selection of delivered amount of energy. • Morpheus8 Burst/Burst Deep handpieces: the Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use tip head accessories. Control of the thermal effect is by selection of delivered amount of energy.Summary parsed at:2026-06-19 06:01:20 UTC
