QTW — Digital Amsler Grid Class I
FDA product code QTW covers "Digital Amsler Grid", a Class I medical device regulated under 21 CFR 886.1330. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QTW
- Device Class
- Class I
- Regulation Number
- 886.1330
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203594 | neuro-eye diagnostic systems | EyeCTester | September 7, 2022 |