LAP-iX2N— 510(k) K253165
Substantially EquivalentSejong Medical Co., Ltd.
FDA 510(k) clearance K253165 for LAP-iX2N, Substantially Equivalent on 2026-06-09. Applicant: Sejong Medical Co., Ltd.. Device class: 2.
Summary
Sejong Medical's LAP-iX2N is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't describe the device beyond the model name and the code name.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Sejong filed from Gyeonggi-Do, South Korea. Review took 256 calendar days (September 26, 2025 to June 9, 2026).
Clearance details
- Applicant
- Sejong Medical Co., Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gyeonggi-Do, KR
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More clearances from Sejong Medical Co., Ltd.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.