FDA Clearance for the Rejuvapen NXT®

Updated: Oct 4

Refine USA was granted a class II medical clearance from the FDA for its medical grade microneedling device: Rejuvapen NXT®. 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 recent FDA clearance of the Rejuvapen NXT is a game changer in the industry. This microneedling device brings major technological advances to the market with its nine 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 expect.


"We are proud to announce the RejuvapenNXT 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," Anthony Johnson, President of Sales at Refine USA, said.


The RejuvapenNXT 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.


Microneedling has proven to be safe and effective. Patients can now experience fantastic results with a device that is not highly invasive. Benefits include:

  • Safe and effective for all skin types

  • Very little downtime

  • Short procedure time

  • Very little pain and discomfort

  • Ideal for use any time of the year including the summer months with little restriction after treatment

Refine USA, “Your Aesthetic Partner” is headquartered in Jacksonville Beach, FL and has been an industry leader in medical aesthetics since 2006. Its product portfolio, in addition to the Rejuvapen NXT, consists of the PureSpin PRP product line, the Kimera Exosome product line and Ontogeny C growth factor products, among others.


Refine USA is continually expanding its profile offering products that enhance the patients’ experiences while supporting our providers with cutting edge technologies to expand their practice and drive revenue growth.


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