K253484
- 510(k) number
- K253484
- Device name
- LUTRONIC GENIUS
- Applicant
- Cynosure Lutronic Technology Corporation KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-06-29
- Date received
- 2025-10-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K253484.pdf
Official FDA record: K253484
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.