510(k) K222484
- Device
- Retitrack
- Applicant
- C. Light Technologies, Inc.
- 510(k) number
- K222484
- Product code
- HLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-09
- Date received
- 2022-08-17
- Regulation
- 886.1510
- Classification name
- Monitor, Eye Movement
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Christy K Sheehy-Bensinger
- Address
- 84 High St., Suite 303 Medford MA US 02155 02155
FDA Registration Numbers#
- 3005785090
- 3027593072
- 3003553186
- 2031962