K242553
- 510(k) number
- K242553
- Device name
- MIRARI® Cold Plasma System ( GV-M2-01)
- Applicant
- General Vibronics, Inc. AZ · US
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2024-11-21
- Date received
- 2024-08-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242553.pdf
Official FDA record: K242553
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.