Cleared Traditional

K192138 - Rejuvapen NXT

K192138 is an FDA 510(k) clearance for Rejuvapen NXT, manufactured by Refine USA, LLC. The device is a Class 2 General & Plastic Surgery device with product code QAI cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K192138 · Refine USA, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
245d
Days
Class 2
Risk

K192138 is an FDA 510(k) clearance for the Rejuvapen NXT. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Refine USA, LLC (Jacksonville Beach, US). The FDA issued a Cleared decision on April 9, 2020 after a review of 245 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4430 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Refine USA, LLC devices

FDA 510(k) Submission Details - K192138

510(k) Number K192138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2019
Decision Date April 09, 2020
Days to Decision 245 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QAI Device Classification - Class 2, Special Controls

Product Code QAI Powered Microneedle Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4430
Definition A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Technireg, Inc.
Wayne Glover

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QAI Powered Microneedle Device

All 25
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