HLL · Monitor, Eye Movement
Ophthalmic · 21 CFR 886.1510 · Class 2
Overview
| Product Code | HLL |
|---|---|
| Device Name | Monitor, Eye Movement |
| Regulation | 21 CFR 886.1510 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
Classification Rationale
Class II.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222484 | Retitrack | C. Light Technologies, Inc. | May 9, 2023 | SESE |
| K152890 | SACCADOMETER PLUS, SACCADOMETER ADVANCED | Ober Consulting Sp. Z.O.O. | Aug 11, 2016 | SESE |
| K033949 | VARILUX VISIONPRINT SYSTEM (VPS) | Essilor Intl. | Jul 2, 2004 | SESE |
| K872111 | ORTHOTONE | Orthotone Corp. | Nov 16, 1988 | SESE |
Top Applicants
- Orthotone Corp. — 1 clearance
- Ober Consulting Sp. Z.O.O. — 1 clearance
- Essilor Intl. — 1 clearance
- C. Light Technologies, Inc. — 1 clearance
