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FDA 510(k)

LAP-iX2N

K-Number: K253165 · 2026-06-09

ApplicantSejong Medical Co., Ltd.
Decision Date2026-06-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAP-iX2N is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K253165. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAP-iX2N?

LAP-iX2N is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K253165.

When did LAP-iX2N receive FDA 510(k) clearance?

LAP-iX2N received FDA 510(k) clearance on 2026-06-09, under 510(k) number K253165.

Who is the listed applicant for LAP-iX2N?

The FDA 510(k) record lists Sejong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAP-iX2N?

The FDA product code for LAP-iX2N is GEI.

Other records listing Sejong Medical Co., Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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