K242630
- 510(k) number
- K242630
- Device name
- Aerin Console
- Applicant
- Aerin Medical, Inc. CA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-12-10
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242630.pdf
Official FDA record: K242630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.