Refine USA LLC has been granted a class II medical clearance from the FDA for its medical-grade microneedling device, Rejuvapen NXT, the Jacksonville Beach, Fla-based company announces in a news release.
This recent clearance has raised the bar for existing microneedling devices with its mechanical technological advances and expanded its intended use to facial wrinkles, the company suggests.
“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,” says Anthony Johnson, Refine USA President-Sales.
The Rejuvapen NXT has passed multiple electrical and safety tests for biocompatibility, including testing for irritation and cytotoxicity, and sensitization ensuring none of the materials used are harmful to the patient. These tests also include design verification and validation testing. The product is also certified according to ISO/IEC Guide 17067 and in accordance with ANSI/AAMI ES60601, per the release.
[Source(s): Refine USA LLC, Business Wire]