K253826
- 510(k) number
- K253826
- Device name
- Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
- Applicant
- Galvanize Therapeutics, Inc. CA · US
- Product code
- OAB — Low Energy Direct Current Thermal Ablation System
- Decision date
- 2026-05-07
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253826.pdf
Official FDA record: K253826
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.