FDA 510(k)

Photon Therapy Apparatus (BL-10)

K-Number: K243993 · 2025-03-13

ApplicantXemis Medical Technology (Shenzhen) Co., Ltd.

Decision Date2025-03-13

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Photon Therapy Apparatus (BL-10) is a medical device manufactured by Xemis Medical Technology (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-03-13 under approval number K243993. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Photon Therapy Apparatus (BL-10)?

Photon Therapy Apparatus (BL-10) is a medical device that received FDA 510(k) clearance on 2025-03-13. It is manufactured by Xemis Medical Technology (Shenzhen) Co., Ltd.. The 510(k) number is K243993.

When was Photon Therapy Apparatus (BL-10) approved by the FDA?

Photon Therapy Apparatus (BL-10) received FDA 510(k) clearance on 2025-03-13, under approval number K243993.

What company makes Photon Therapy Apparatus (BL-10)?

Photon Therapy Apparatus (BL-10) is manufactured by Xemis Medical Technology (Shenzhen) Co., Ltd..

What is the FDA product code for Photon Therapy Apparatus (BL-10)?

The FDA product code for Photon Therapy Apparatus (BL-10) is GEX. This falls under the Gastroenterology category.

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Other Devices by Xemis Medical Technology (Shenzhen) Co., Ltd.

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Official Source

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