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510(k) Data Aggregation
(267 days)
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.
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:
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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.
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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.
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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.
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