Data / Medical devices / United States / Equipmed Usa LLC
Equipmed Usa LLC: FDA-registered device maker in Newport Beach, CA, United States, 1 510(k) clearance
Equipmed Usa LLC is registered with the FDA (registration 3018153007) in Newport Beach, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018153007
- Address
- 4695 MacArthur Court F11, Newport Beach, CA, United States, 92660
- Owner or operator
- Equipmed USA LLC (10082209)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- March 22, 2023
- Registered through
- 2026
- Brand names listed
- DP4 Micro needling Device, Dermapen 4 Micro needling device, Medipen Micro needling device, dermapen 4 micro needling device, dp4 micro needling device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer for export | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2022 | K221070 | DP4 Microneedling device | QAI | Substantially Equivalent | Equipmed USA, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 20, 2022. 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.