XC11 ICE System, USA
Oct 2025
205d
Yorlabs, Inc.
1
Total
1
Cleared
0
Denied
Yorlabs, Inc. — FDA 510(k) Submissions
Yorlabs, Inc. has submitted 1 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.
The company's most frequent device categories include Catheter, Ultrasound, Intravascular . Use the specialty filter in the sidebar to narrow results.
1 devices