510(k) K222484
K222484 is an FDA 510(k) premarket notification submitted by C. Light Technologies, Inc. for the device "Retitrack". The FDA issued a decision of Substantially Equivalent on May 9, 2023. The device falls under product code HLL (Monitor, Eye Movement), a Class II device regulated under 21 CFR 886.1510.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2023
- Date Received
- August 17, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Eye Movement
- Device Class
- Class II
- Regulation Number
- 886.1510
- Review Panel
- OP
- Submission Type