It's Official...the Rejuvapen NXT is now FDA 510k Cleared!
It's Official...the Rejuvapen NXT is now FDA 510k Cleared!
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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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