Data / Medical devices / United States / Yorlabs, Inc.

Yorlabs, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance

Name: Yorlabs, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Yorlabs, Inc. is registered with the FDA (registration 3038718997) in Carlsbad, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 22, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3038718997
Address: 2210 Faraday Ave Ste 100, Carlsbad, CA, United States, 92008
Owner or operator: YorLabs, Inc. (10094268)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 21, 2025
Registered through: 2026
Brand names listed: XC11 Communication Hub, USA, XC11 ICE Box Ultrasound System, USA, XC11 ICE Catheter (2D), USA, XC11 ICE System Cart, USA, XC11 ICE System Disposable Knob, USA, XC11 ICE System Handle, USA, XC11 ICE System Tablet, USA, XC11 ICE System, USA

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Ultrasound, Intravascular	OBJ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 22, 2025	K250955	XC11 ICE System, USA	OBJ	Substantially Equivalent	Yorlabs, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.