Data / Medical devices / United States / General Vibronics, Inc.
General Vibronics, Inc.: FDA-registered device maker in Tempe, AZ, United States, 1 510(k) clearance
General Vibronics, Inc. is registered with the FDA (registration 3013652305) in Tempe, AZ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 21, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013652305
- Address
- 1615 E Warner Rd Ste 4, Tempe, AZ, United States, 85284
- Owner or operator
- General Vibronics, Inc. (10092586)
- Roles
- Manufacturer
- First device listed
- January 23, 2025
- Registered through
- 2027
- Brand names listed
- MIRARI Cold Plasma System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 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 |
|---|---|---|---|---|---|---|
| November 21, 2024 | K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | PBX | Substantially Equivalent | General Vibronics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated November 21, 2024. 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.