K253803
- 510(k) number
- K253803
- Device name
- MILAN System
- Applicant
- Lumenis Be, Ltd. IL
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-06-02
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K253803.pdf
Official FDA record: K253803
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.