HOX · Chart, Visual Acuity
Ophthalmic · 21 CFR 886.1150 · Class 1
Overview
| Product Code | HOX |
|---|---|
| Device Name | Chart, Visual Acuity |
| Regulation | 21 CFR 886.1150 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.
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 (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K100095 | CENTRAL VISION ANALYZER MODEL 1000 | Vimetrics,Llc. | May 10, 2010 | SESE |
| K944156 | HEINE LAMBDA 100 | Heine USA , Ltd. | Jan 12, 1995 | SESE |
| K881971 | OCCU-TECH VISION TEST | Applied Vision Concepts, Inc. | Nov 25, 1988 | SESE |
| K883337 | PL 20/20 INFANT VISION TESTER | Optimed Technologies, Inc. | Oct 31, 1988 | SESE |
| K882634 | VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE | Vistech Consultants, Inc. | Jul 15, 1988 | SESE |
| K881358 | PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM | Neuroscientific Corp. | Jun 27, 1988 | SESE |
| K881059 | MCT 8000 (MULTI-VISION CONTRAST TESTER) | Vistech Consultants, Inc. | Apr 4, 1988 | SESE |
| K881023 | VCTS 6500 SYSTEM | Vistech Consultants, Inc. | Apr 1, 1988 | SESE |
| K881022 | VCTS MARKETING PROGRAM SYSTEM | Vistech Consultants, Inc. | Apr 1, 1988 | SESE |
| K881021 | VCTS 700S SYSTEM | Vistech Consultants, Inc. | Apr 1, 1988 | SESE |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Fred Sammons, Inc. | Apr 1, 1988 | SESE |
| K875237 | OPTEC 1000 DMV VISION TESTER MODIFY | Stereo Optical Co., Inc. | Mar 17, 1988 | SESE |
| K875112 | MENTOR B-VAT(TM) II VIDEO TESTER | Mentor O & O, Inc. | Mar 8, 1988 | SESE |
| K873916 | 'E' CUBE AND 'E' PAD | Richmond Products, Inc. | Dec 11, 1987 | SESE |
| K873909 | READING CHARTS-CARDS (DISTANCE AND NEARPOINT) | Richmond Products, Inc. | Oct 28, 1987 | SESE |
| K863509 | OPTEC 1000 DMV | Stereo Optical Co., Inc. | Nov 10, 1986 | SESE |
| K861416 | CANON AUTO ACUITOMETER CV-10 | Canon USA, Inc. | May 14, 1986 | SESE |
| K854983 | OPTRONICS CONTRAST ACUITY TESTER | Optronics, Inc. | Feb 4, 1986 | SESE |
| K854047 | IN-HOME VISION MONITORING KIT | Rich-Larky Company, Inc. | Dec 13, 1985 | SESE |
| K853736 | MENTOR BRIGHTNESS ACUITY TESTER | Mentor O & O, Inc. | Nov 1, 1985 | SESE |
Top Applicants
- Vistech Consultants, Inc. — 7 clearances
- Mentor O & O, Inc. — 3 clearances
- Stereo Optical Co., Inc. — 2 clearances
- Richmond Products, Inc. — 2 clearances
- Vimetrics,Llc. — 1 clearance
