It's Official...the Rejuvapen NXT is now FDA 510k Cleared!
REFINE USA, LLC, a leader in cosmetic medical aesthetic devices since 2006, has been granted a class 2 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.
"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 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.” Said 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 test 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 and our patients can now experience fantastic results with a device that is not highly invasive, including:
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, amongst others Refine USA is continually expanding its profile offering products that will enhance the patients' experience while supporting our providers with cutting edge technologies to expand their practice and drive revenue growth.
Regulatory Status: The PureSpin is an FDA cleared 510 (K) Class II medical device. PureSpin PRP® is intended for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograph or allograft bone prior to application to an orthopedic surgical site. 510 (K ) number BK050055. The Rejuvapen® is marketed for and has an intended use for micro-pigmentation treatments. The Apex Magnum® has an intended use as a Therapeutic massager under Sec. 890.5660. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains. The Rejuvapen NXT ® is marketed for and has an intended use as a micro-pigmentation treatments.
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