FDA 510(k)

XC11 ICE System, USA

K-Number: K250955 · 2025-10-22

Decision Date2025-10-22

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

XC11 ICE System, USA is a medical device manufactured by Yorlabs, Inc.. It received FDA 510(k) clearance on 2025-10-22 under approval number K250955. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XC11 ICE System, USA?

XC11 ICE System, USA is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Yorlabs, Inc.. The 510(k) number is K250955.

When was XC11 ICE System, USA approved by the FDA?

XC11 ICE System, USA received FDA 510(k) clearance on 2025-10-22, under approval number K250955.

What company makes XC11 ICE System, USA?

XC11 ICE System, USA is manufactured by Yorlabs, Inc..

What is the FDA product code for XC11 ICE System, USA?

The FDA product code for XC11 ICE System, USA is OBJ.

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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.