The Rejuvapen NXT microneedling device has cleared multiple electrical and safety tests for biocompatibility

FDA device

The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Refine USA has secured a class II medical clearance from the US Food and Drug Administration (FDA) for its medical grade microneedling device.

The Rejuvapen NXT microneedling device, which is intended for facial wrinkles, has cleared multiple electrical and safety tests for biocompatibility such as testing for irritation and cytotoxicity, and sensitisation.

The tests also comprise of design verification and validation testing. The benefits offered by microneedling include safe and effective for all skin types, very little downtime, short procedure time and very little pain and discomfort.

The medical-grade microneedling device is suitable for use in any time of the year

The device can be used in any time of the year, including the summer months with little restriction after treatment.

Refine USA sales president Anthony Johnson said: “Our recent FDA clearance for the patent pending Rejuvapen NXT is without a doubt, a game changer in the industry. Our device brings major technological advancements to the market with its multiple (9) speed settings, precise infinite dial, and digital motor.

“The health care provider now has the flexibility to customize each patient’s facial treatment to produce the consistent clinical results today’s consumers demand.

“We are proud to announce the Rejuvapen NXT is manufactured in the USA and we have positioned our unit and consumable pricing to be nearly 50% less than the other FDA cleared microneedling systems available today.”

Based in Jacksonville Beach of Florida, Refine USA manufactures products, including Rejuvapen NXT, PureSpin PRP products, Kimera Exosome products and Ontogeny C growth factor products.

In February this year, Cynosure secured FDA clearance or its Potenza radiofrequency (RF) microneedling device.

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