Data / Medical devices / United States / Refine Usa, LLC
Refine Usa, LLC: FDA-registered device maker in Jacksonville Beach, FL, United States, 1 510(k) clearance
Refine Usa, LLC is registered with the FDA (registration 3006033709) in Jacksonville Beach, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006033709
- Address
- 340 3rd Avenue S, Jacksonville Beach, FL, United States, 32250
- Owner or operator
- REFINE USA, LLC (9095020)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- June 14, 2018
- Registered through
- 2026
- Brand names listed
- Apex, Rejuvapen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2020 | K192138 | Rejuvapen NXT | QAI | Substantially Equivalent | Refine USA, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 9, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.