K260255
- 510(k) number
- K260255
- Device name
- AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
- Applicant
- Aventix Medical, Inc. CA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-03-27
- Date received
- 2026-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260255.pdf
Official FDA record: K260255
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.