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510(k) K192138

Rejuvapen NXT by Refine USA, LLC — Product Code QAI

K192138 is an FDA 510(k) premarket notification submitted by Refine USA, LLC for the device "Rejuvapen NXT". The FDA issued a decision of Substantially Equivalent on Apr 9, 2020. The device falls under product code QAI (Powered Microneedle Device), a Class II device regulated under 21 CFR 878.4430. Refine USA, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 9, 2020
Date Received
Aug 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Microneedle Device
Device Class
Class II
Regulation Number
878.4430
Review Panel
SU
Submission Type

A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.

Other clearances by Refine USA, LLC

  • K112334 — VEIN-GOGH INSTRUMENT (May 8, 2012)

Other clearances for product code QAI

  • K252591 — Automatic Micro Needle System (CODE-X) (May 13, 2026)
  • K253002 — SkinStylus SteriLock MicroSystem (MP1209SL) (Feb 19, 2026)
  • K252752 — ellacor System with Micro-Coring Technology (Oct 30, 2025)
  • K253153 — SER Pen Carain MicroSystem (MP1209SP) (Oct 29, 2025)
  • K243800 — PRO Pen Microneedling System (6883) (Aug 25, 2025)
  • K243143 — E-PEN (E-PEN) (Apr 7, 2025)
  • K243472 — 1NEED Pro (Mar 19, 2025)
  • K241790 — XCELLARISPRO TWIST microneedling device (Mar 6, 2025)
  • K241355 — SER Pen Carain MicroSystem (MP1209SP) (Oct 9, 2024)
  • K241400 — SkinPen Precision Elite System (Aug 29, 2024)

FDA data resources