Digital Amsler Grid
The Digital Amsler Grid is an ophthalmic diagnostic device used as an aid in detecting central visual irregularities caused by changes in the visual pathway, including conditions such as macular degeneration or other macular disorders. It provides a digital version of the classic Amsler grid test administered on a screen or electronic display. Classified as FDA Class 1 under regulation 886.1330, it is subject to general controls only and is 510(k) exempt in the Ophthalmic specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QTW
- Device Class
- FDA class 1
- Regulation Number
- 886.1330
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203594 | EyeCTester | Sep 07, 2022 | Substantially Equivalent | Neuro-Eye Diagnostic Systems, LLC |
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.