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The Tracker / August 2026 / K260236

510(k) cleared

XLITE

GEMSS HEALTHCARE CO., LTD. · Aug 3, 2026 · K260236

FDA cleared the XLITE from GEMSS HEALTHCARE CO., LTD. on Aug 3, 2026 under K260236, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code IZL, System, X-Ray, Mobile, regulated at 21 CFR 892.1720 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 26, 2026. The decision came 189 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for GEMSS HEALTHCARE CO., LTD. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260236?

K260236 is the FDA 510(k) for XLITE, submitted by GEMSS HEALTHCARE CO., LTD.. FDA's decision date was Aug 3, 2026, under product code IZL (System, X-Ray, Mobile).

Who makes the XLITE?

GEMSS HEALTHCARE CO., LTD., based in Paju-Si, is the applicant of record for K260236.

How long did the K260236 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Aug 3, 2026, 189 days later.

← All decisions in August 2026