Yorlabs, Inc.
United Statesfrom the FDA registration address FDA FEI 3038718997
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Yorlabs, Inc. makes
Yorlabs, Inc. manufactures the XC11 ICE System, a medical device designed for cryoablation procedures, which uses controlled freezing to treat targeted tissues.
The XC11 ICE System is classified as a Class II device under FDA regulations and is listed in the 510(k) clearance registry. The company is based in the United States.
Catalogue
XC11 ICE System, USA Ref K250955
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3038718997
- Address
- 2210 Faraday Ave Ste 100, Carlsbad, CA, 92008
Frequently asked questions
How many devices does Yorlabs, Inc. have in the registry?
The registry currently lists 1 device for Yorlabs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Yorlabs, Inc.'s devices?
Among its 1 most recently registered device, Yorlabs, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Yorlabs, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Yorlabs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Yorlabs, Inc. in the registry?
The most recently registered devices listed for Yorlabs, Inc. include XC11 ICE System, USA.