K252576
- 510(k) number
- K252576
- Device name
- Legend X Platform
- Applicant
- Pollogen, Ltd. IL
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-09-12
- Date received
- 2025-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Flag
- Third-party review
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252576.pdf
Official FDA record: K252576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.