The following data is part of a premarket notification filed by Refine Usa Llc with the FDA for Rejuvapen Nxt.
| Device ID | K192138 |
| 510k Number | K192138 |
| Device Name: | Rejuvapen NXT |
| Classification | Powered Microneedle Device |
| Applicant | Refine USA LLC 340 3rd Avenue South Suite C Jacksonville Beach, FL 32250 |
| Contact | Brian Smith |
| Correspondent | Wayne Glover TechniReg, Inc 19404 Pine Valley Drive Odessa, FL 33556 -3955 |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-08 |
| Decision Date | 2020-04-09 |