Back to All NewsRefine USA's Rejuvapen NXT Microneedling System Earns FDA Clearance
Posted By American Med Spa Association, Thursday, April 16, 2020
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Refine USA has been granted a class 2 medical clearance from the FDA for its medical grade microneedling device, Rejuvapen NXT. This recent clearance has expanded its intended use to facial wrinkles.
The Rejuvapen NXT has passed multiple electrical and safety tests for biocompatibility, including testing for irritation, cytotoxicity and sensitization, ensuring none of the materials used are harmful to the patient. These tests include design verification and validation testing. The product is also certified according to ISO/IEC Guide 17067 and in accordance with ANSI/AAMI ES60601.
Click here to learn more about the Rejuvapen NXT >>
The Rejuvapen NXT has passed multiple electrical and safety tests for biocompatibility, including testing for irritation, cytotoxicity and sensitization, ensuring none of the materials used are harmful to the patient. These tests include design verification and validation testing. The product is also certified according to ISO/IEC Guide 17067 and in accordance with ANSI/AAMI ES60601.
Click here to learn more about the Rejuvapen NXT >>
