Benchmed logo
Categories

Ignite RF System

InMode , Ltd.

Country / Region:Israel (IL)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

Israel (IL)

Product code

GEI
21 CFR 878.4400

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251254
Device name
Ignite RF System
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

Predicate devices

2

K251254 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251254 as a predicate