XC11 ICE System, USA
FDA 510(k) clearance K250955 · decided 2025-10-22
Clearance details
- K-number
- K250955
- Device name
- XC11 ICE System, USA
- Applicant
- Yorlabs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-31
- Decision date
- 2025-10-22
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.