Chart, Visual Acuity
FDA product code HOX · Class I (low risk) · 21 CFR 886.1150 · Ophthalmic
32510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
- Vistech Consultants, Inc. 7
- Mentor O & O, Inc. 3
- Richmond Products, Inc. 2
- Stereo Optical Co., Inc. 2
- Vimetrics,Llc. 1
- Codman & Shurtleff, Inc. 1
- Applied Vision Concepts, Inc. 1
- Optimed Technologies, Inc. 1
- Neuroscientific Corp. 1
- Fred Sammons, Inc. 1
- Canon USA, Inc. 1
- Optronics, Inc. 1
- Rich-Larky Company, Inc. 1
- American Ergo Systems 1
- Good-Lite Co. 1
- Technical Enginuities Co. 1
- CooperVision, Inc. 1
- Nicolet Biomedical Instruments 1
- Abco Dealers, Inc. 1
- Eyedex 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100095 | Central Vision Analyzer Model 1000HOX · Abbreviated | Vimetrics,Llc. | 05/10/2010SE |
| K944156 | Heine Lambda 100HOX · Traditional | Heine USA , Ltd. | 01/12/1995SE |
| K881971 | Occu-Tech Vision TestHOX · Traditional | Applied Vision Concepts, Inc. | 11/25/1988SE |
| K883337 | PL 20/20 Infant Vision TesterHOX · Traditional | Optimed Technologies, Inc. | 10/31/1988SE |
| K882634 | Visual Contrast Sensiti., Potential Acuity&GlareHOX · Traditional | Vistech Consultants, Inc. | 07/15/1988SE |
| K881358 | PG Consen Contrast Sensitivity Testing ProgramHOX · Traditional | Neuroscientific Corp. | 06/27/1988SE |
| K881059 | MCT 8000 (Multi-Vision Contrast Tester)HOX · Traditional | Vistech Consultants, Inc. | 04/04/1988SE |
| K881023 | VCTS 6500 SystemHOX · Traditional | Vistech Consultants, Inc. | 04/01/1988SE |
| K881022 | VCTS Marketing Program SystemHOX · Traditional | Vistech Consultants, Inc. | 04/01/1988SE |
| K881021 | VCTS 700S SystemHOX · Traditional | Vistech Consultants, Inc. | 04/01/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | Fred Sammons, Inc. | 04/01/1988SE |
| K875237 | Optec 1000 DMV Vision Tester ModifyHOX · Traditional | Stereo Optical Co., Inc. | 03/17/1988SE |
| K875112 | Mentor B-Vat(Tm) II Video TesterHOX · Traditional | Mentor O & O, Inc. | 03/08/1988SE |
| K873916 | 'E' Cube and 'E' PadHOX · Traditional | Richmond Products, Inc. | 12/11/1987SE |
| K873909 | Reading Charts-Cards (Distance and Nearpoint)HOX · Traditional | Richmond Products, Inc. | 10/28/1987SE |
| K863509 | Optec 1000 DMVHOX · Traditional | Stereo Optical Co., Inc. | 11/10/1986SE |
| K861416 | Canon Auto Acuitometer CV-10HOX · Traditional | Canon USA, Inc. | 05/14/1986SE |
| K854983 | Optronics Contrast Acuity TesterHOX · Traditional | Optronics, Inc. | 02/04/1986SE |
| K854047 | In-Home Vision Monitoring KitHOX · Traditional | Rich-Larky Company, Inc. | 12/13/1985SE |
| K853736 | Mentor Brightness Acuity TesterHOX · Traditional | Mentor O & O, Inc. | 11/01/1985SE |
| K853481 | Vistech VCTS Glare TesterHOX · Traditional | Vistech Consultants, Inc. | 10/29/1985SE |
| K840255 | Vistech VCTS 6000HOX · Traditional | Vistech Consultants, Inc. | 04/13/1984SE |
| K834145 | Ergo Diagnostic CardHOX · Traditional | American Ergo Systems | 03/16/1984SE |
| K833956 | Dot Visual Acvity Test 2000HOX · Traditional | Good-Lite Co. | 01/04/1984SE |
| K833778 | Testing Visual AcuityHOX · Traditional | Technical Enginuities Co. | 01/04/1984SE |
| K830011 | VFS 1000/SCREENING Function AnalyzerHOX · Traditional | CooperVision, Inc. | 01/17/1983SE |
| K822215 | Nic Optronics CS-2000HOX · Traditional | Nicolet Biomedical Instruments | 08/31/1982SE |
| K821932 | Mentor Potential Acuity MeterHOX · Traditional | Mentor O & O, Inc. | 08/03/1982SE |
| K813376 | Eye ChartsHOX · Traditional | Abco Dealers, Inc. | 01/07/1982SE |
| K803256 | Eyetech-Vision Screening SystemHOX · Traditional | Eyedex | 03/04/1981SE |
| K790909 | Ophthalmic Dressing TrayHOX · Traditional | Pent-Cal, Inc. | 08/03/1979SE |
| K781452 | Baylow Visual Acuity TesterHOX · Traditional | Codman & Shurtleff, Inc. | 10/24/1978SE |