Monitor, Eye Movement
The Eye Movement Monitor is an ophthalmic device that tracks and records the position, velocity, and pattern of eye movements, used in the diagnosis of nystagmus, vestibular disorders, and neurological conditions affecting ocular motility. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence before marketing. The product code is HLL, regulated under 21 CFR 886.1510, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.
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Basic Information
- Product Code
- HLL
- Device Class
- FDA class 2
- Regulation Number
- 886.1510
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222484 | Retitrack | May 09, 2023 | Substantially Equivalent | C. Light Technologies, Inc. |
| K152890 | SACCADOMETER PLUS, SACCADOMETER ADVANCED | Aug 11, 2016 | Substantially Equivalent | Ober Consulting Sp. Z.O.O. |
| K033949 | VARILUX VISIONPRINT SYSTEM (VPS) | Jul 02, 2004 | Substantially Equivalent | Essilor Intl. |
| K872111 | ORTHOTONE | Nov 16, 1988 | Substantially Equivalent | Orthotone Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.