LAP-iX2N
FDA 510(k) clearance K253165 · decided 2026-06-09
Clearance details
- K-number
- K253165
- Device name
- LAP-iX2N
- Applicant
- Sejong Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2026-06-09
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.