Grid, Amsler
An Amsler Grid is a simple diagnostic ophthalmic tool consisting of a pattern of horizontal and vertical lines with a central fixation point, used by patients and clinicians to detect and monitor distortions or defects in central vision associated with macular disease such as age-related macular degeneration. This device is FDA Class 1 (lowest risk), subject to general controls without requiring premarket submission. It carries product code HOQ and is regulated under 21 CFR 886.1330, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- HOQ
- Device Class
- FDA class 1
- Regulation Number
- 886.1330
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K180895 | Alleye | Jun 27, 2018 | Substantially Equivalent | Oculocare Medical AG |
| K143211 | myVision Track Model 005 | Mar 20, 2015 | Substantially Equivalent | Vital Art and Science Incorporated |
| K121738 | MYVISIONTRACK(TM) | Feb 22, 2013 | Substantially Equivalent | Vital Art and Science Incorporated |
| K014044 | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) | Mar 04, 2002 | Substantially Equivalent | Notal Vision, Inc. |
| K874252 | KREDA DISC | Jan 27, 1988 | Substantially Equivalent | Richmond Products, Inc. |
| K863429 | MODIFIED DEVICE FOR SELF EXAMINATION OF EYES | Jan 20, 1987 | Substantially Equivalent | Wheel Checkers |
| K843227 | MACULAR FUNCTION ANALYZER | Jul 22, 1985 | Substantially Equivalent | Danek Medical, Inc. |
| K843702 | APPARATUS & METHODS SELF-EXAM OF EYE | Jan 03, 1985 | Substantially Equivalent | Wheel Checkers |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.