InMode RF Pro system

Trade name

InMode RF Pro system

17290016633662

7290016633IRF100x92

Reference / catalog number

AG609482A

GS1

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The InMode RF Pro system employs radiofrequency (RF) energy for use in radio frequency-assisted liposuction/lipolysis dermatological procedures.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• X0401EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOSUCTION
• X0402EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOLYSIS

1 warning recorded — scroll inside the panel to see all entries.

• This equipment is for use only by trained, licensed physicians. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and the consumer’s safety. Careful consideration shall be given to consumer suitability with respect to medication which has the potential to cause bradycardia or hypotension. Consumers taking drugs such as beta-adrenergic antagonists, non- dihydropyridine calcium-channel blockers, cardiac glycosides, and centrally acting alpha-adrenergic agonists shall be subject to very careful consideration. The procedure has to be preceded by a medical consultation. Consumers may experience extended post-operative which may result in reduced sensation in the areas infiltrated. Liver or cardiovascular dysfunction, such as the transient release of glycerol or free fatty acid, may be associated with increased risk. Medical doctors performing the procedure shall also be trained in advanced cardiac life support. Appropriate post-procedure monitoring shall be in place as lidocaine levels have been found to rise for up to 16 hours post-delivery. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit. Always turn off and unplug the device before cleaning. The consumer should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth. The use of antistatic sheeting is recommended for this purpose. Use the lowest output setting necessary to achieve the desired treatment effect. When IgniteRF and physiological monitoring EQUIPMENT are used simultaneously on the same consumer; any monitoring electrodes should be placed as far as possible from the handpiece electrodes. Always observe fire precautions. Do not use IgniteRF on subjects with pacemakers or internal defibrillators.

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