K192138 is an FDA 510(k) clearance for the Rejuvapen NXT. This device is classified as a Powered Microneedle Device (Class II - Special Controls, product code QAI).
Submitted by Refine USA, LLC (Jacksonville Beach, US). The FDA issued a Cleared decision on April 9, 2020, 245 days after receiving the submission on August 8, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4430. A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use..
| 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 |
| Product Code | QAI - Powered Microneedle Device |
| Device Class | Class II - 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. |