510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192138Substantially Equivalent

Rejuvapen NXT

Refine USA, LLC, Jacksonville Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192138 is the FDA 510(k) clearance record for Rejuvapen NXT, a class II device, cleared for Refine USA, LLC on under FDA product code QAI (Powered Microneedle Device). FDA's definition for product code QAI reads: "A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use". FDA records list 2 510(k) clearances for Refine USA, LLC, from to . As of , FDA records show no recalls naming K192138.

Clearance record

Decision date
Received
(245 days to decision)
Product code
QAI Powered Microneedle Device
Regulation
21 CFR 878.4430
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Refine USA, LLC 340 3rd Ave. S. Suite C, Jacksonville Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAI

Trailing 12 months
2 clearances under product code QAI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260