K253165
- 510(k) number
- K253165
- Device name
- LAP-iX2N
- Applicant
- Sejong Medical Co., Ltd. KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-06-09
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253165.pdf
Official FDA record: K253165
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.