K243217
- 510(k) number
- K243217
- Device name
- Legend X Desktop System
- Applicant
- Pollogen, Ltd. IL
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-11-01
- Date received
- 2024-10-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243217.pdf
Official FDA record: K243217
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.