HOQ · Grid, Amsler
Ophthalmic · 21 CFR 886.1330 · Class 1
Overview
| Product Code | HOQ |
|---|---|
| Device Name | Grid, Amsler |
| Regulation | 21 CFR 886.1330 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180895 | Alleye | Oculocare Medical AG | Jun 27, 2018 | SESE |
| K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | Mar 20, 2015 | SESE |
| K121738 | MYVISIONTRACK(TM) | Vital Art and Science Incorporated | Feb 22, 2013 | SESE |
| K014044 | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) | Notal Vision, Inc. | Mar 4, 2002 | SESE |
| K874252 | KREDA DISC | Richmond Products, Inc. | Jan 27, 1988 | SESE |
| K863429 | MODIFIED DEVICE FOR SELF EXAMINATION OF EYES | Wheel Checkers | Jan 20, 1987 | SESE |
| K843227 | MACULAR FUNCTION ANALYZER | Danek Medical, Inc. | Jul 22, 1985 | SESE |
| K843702 | APPARATUS & METHODS SELF-EXAM OF EYE | Wheel Checkers | Jan 3, 1985 | SESE |
Top Applicants
- Wheel Checkers — 2 clearances
- Vital Art and Science Incorporated — 2 clearances
- Richmond Products, Inc. — 1 clearance
- Oculocare Medical AG — 1 clearance
- Notal Vision, Inc. — 1 clearance
