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FDA Cleared Microneedling Pen Rejuvapen NXT®

Made In The USA

The Rejuvapen NXT is an FDA 510(k) cleared microneedling pen (K192138) designed for licensed aesthetic practitioners. Manufactured in the USA, it delivers precise, controlled micro-needling treatments for facial wrinkles and skin rejuvenation — at nearly 50% less cost than competing FDA-cleared systems.

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Rejuvapen NXT FDA Clearance Details

  • 510(k) Number: K192138

  • Clearance Date: April 9, 2020

  • Manufacturer: Refine USA LLC

  • Classification: Class II Medical Device

  • Intended Use: Improve appearance of periorbital wrinkles in Fitzpatrick skin types I-IV

 

FDA Clearance:

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192138.pdf

Why Practitioners Choose Rejuvapen NXT

  • 9 speed settings (80–110 Hz)

  • Infinite dial: 0.02–2.5mm depth

  • 12 stainless steel needles, circular arrangement

  • ISO Seal™ barrier technology

  • Plug-in system (no battery fade)

  • Manufactured in the USA

  • ~50% lower device and consumable cost vs. SkinPen

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