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FDA 510(k)

XLITE

K-Number: K260236 · 2026-08-03

ApplicantGEMSS HEALTHCARE CO., LTD.
Decision Date2026-08-03
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XLITE is the device name listed in this FDA 510(k) record. The listed applicant is GEMSS HEALTHCARE CO., LTD.. It received FDA 510(k) clearance on 2026-08-03 under 510(k) number K260236. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLITE?

XLITE is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is GEMSS HEALTHCARE CO., LTD.. The 510(k) number is K260236.

When did XLITE receive FDA 510(k) clearance?

XLITE received FDA 510(k) clearance on 2026-08-03, under 510(k) number K260236.

Who is the listed applicant for XLITE?

The FDA 510(k) record lists GEMSS HEALTHCARE CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XLITE?

The FDA product code for XLITE is IZL.

Other records listing GEMSS HEALTHCARE CO., LTD. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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