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HomeRegulatory ApprovalsFDA approves Cynosure’s Potenza radiofrequency microneedling device

FDA approves Cynosure’s Potenza radiofrequency microneedling device

Medical aesthetics company Cynosure has secured approval from the US Food and Drug Administration (FDA) for its Potenza radiofrequency (RF) microneedling device.

Potenza is claimed to be the first and only FDA-approved four-mode RF microneedling device, which enables clinicians to offer better-personalised treatments for patients.

The device has been designed for electrocoagulation and hemostasis of soft tissue for dermatologic conditions.

Potenza’s four modes, including monopolar and bipolar, allows to provide customised microneedling treatments for patients and enables practitioners to offer both shallow and deep treatments on a single system.

The monopolar RF mode of the device provides energy across a large area of tissue for deep heating and skin tightening via soft tissue coagulation on any part of the body.

The bipolar RF mode of the device helps to deliver concentrated energy for the treatment of superficial tissue, as well as allows to deliver better skin revitalization results.

Potenza device features Tiger Tip technology that enables to expand the treatment zone

The Potenza device also features Tiger Tip technology, a semi-insulated needle technology that helps practitioners to expand the treatment zone and address more tissue per treatment. It is also provided with a single-needle handpiece to target and improve the blemishes.

Potenza treatments apply needles and radiofrequency energy to enter into the top layer of the skin, as well as advance the body’s natural healing process to regenerate new collagen and elastin.

Cynosure CEO Todd Tillemans said: “Our goal at Cynosure is to provide our customers with revolutionary technologies so they can consistently deliver outstanding results.

“Potenza takes the microneedling category to a new level by offering unprecedented flexibility for doctors, which translates to personalized treatments and satisfied patients with exceptional outcomes.”

In November 2019, Clayton, Dubilier & Rice (CD&R) agreed to acquire Cynosure from Hologic for $205m. Cynosure is involved in the development, manufacturing, and commercialisation of medical aesthetic treatment systems.

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