Data / Medical devices / United States / Brera Medical Incorporated
Brera Medical Incorporated: FDA-registered device maker in Northborough, MA, United States, 1 510(k) clearance
Brera Medical Incorporated is registered with the FDA (registration 3012616488) in Northborough, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012616488
- Address
- 44 Bearfoot Rd Ste 216, Northborough, MA, United States, 01532
- Owner or operator
- Brera Medical Incorporated (10033493)
- Roles
- Manufacturer
- First device listed
- August 24, 2010
- Registered through
- 2026
- Brand names listed
- Plasmage, SONOderma
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| April 6, 2022 | K202106 | Plasmage System | GEI | Substantially Equivalent | Brera Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Dermabrasion, Powered
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated April 6, 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.