Product code HOX
- Device name
- Chart, Visual Acuity
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1150
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100095 | CENTRAL VISION ANALYZER MODEL 1000 | Vimetrics,Llc. | 2010-05-10 |
| K944156 | HEINE LAMBDA 100 | Heine USA , Ltd. | 1995-01-12 |
| K881971 | OCCU-TECH VISION TEST | Applied Vision Concepts, Inc. | 1988-11-25 |
| K883337 | PL 20/20 INFANT VISION TESTER | Optimed Technologies, Inc. | 1988-10-31 |
| K882634 | VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE | Vistech Consultants, Inc. | 1988-07-15 |
| K881358 | PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM | Neuroscientific Corp. | 1988-06-27 |
| K881059 | MCT 8000 (MULTI-VISION CONTRAST TESTER) | Vistech Consultants, Inc. | 1988-04-04 |
| K881023 | VCTS 6500 SYSTEM | Vistech Consultants, Inc. | 1988-04-01 |
| K881022 | VCTS MARKETING PROGRAM SYSTEM | Vistech Consultants, Inc. | 1988-04-01 |
| K881021 | VCTS 700S SYSTEM | Vistech Consultants, Inc. | 1988-04-01 |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Fred Sammons, Inc. | 1988-04-01 |
| K875237 | OPTEC 1000 DMV VISION TESTER MODIFY | Stereo Optical Co., Inc. | 1988-03-17 |
| K875112 | MENTOR B-VAT(TM) II VIDEO TESTER | Mentor O & O, Inc. | 1988-03-08 |
| K873916 | 'E' CUBE AND 'E' PAD | Richmond Products, Inc. | 1987-12-11 |
| K873909 | READING CHARTS-CARDS (DISTANCE AND NEARPOINT) | Richmond Products, Inc. | 1987-10-28 |
| K863509 | OPTEC 1000 DMV | Stereo Optical Co., Inc. | 1986-11-10 |
| K861416 | CANON AUTO ACUITOMETER CV-10 | Canon USA, Inc. | 1986-05-14 |
| K854983 | OPTRONICS CONTRAST ACUITY TESTER | Optronics, Inc. | 1986-02-04 |
| K854047 | IN-HOME VISION MONITORING KIT | Rich-Larky Company, Inc. | 1985-12-13 |
| K853736 | MENTOR BRIGHTNESS ACUITY TESTER | Mentor O & O, Inc. | 1985-11-01 |
| K853481 | VISTECH VCTS GLARE TESTER | Vistech Consultants, Inc. | 1985-10-29 |
| K840255 | VISTECH VCTS 6000 | Vistech Consultants, Inc. | 1984-04-13 |
| K834145 | ERGO DIAGNOSTIC CARD | American Ergo Systems | 1984-03-16 |
| K833956 | DOT VISUAL ACVITY TEST 2000 | Good-Lite Co. | 1984-01-04 |
| K833778 | TESTING VISUAL ACUITY | Technical Enginuities Co. | 1984-01-04 |
| K830011 | VFS 1000/SCREENING FUNCTION ANALYZER | CooperVision, Inc. | 1983-01-17 |
| K822215 | NIC OPTRONICS CS-2000 | Nicolet Biomedical Instruments | 1982-08-31 |
| K821932 | MENTOR POTENTIAL ACUITY METER | Mentor O & O, Inc. | 1982-08-03 |
| K813376 | EYE CHARTS | Abco Dealers, Inc. | 1982-01-07 |
| K803256 | EYETECH-VISION SCREENING SYSTEM | Eyedex | 1981-03-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B43050085700 | GoCheck Kids | Gobiquity, Inc. | 2026-01-09 |
| 04987669204917 | Open-field Refraction System | NIDEK CO.,LTD. | 2026-01-08 |
| 04987669204610 | Open-field Refraction System | NIDEK CO.,LTD. | 2026-01-08 |
| 08800019601074 | Visual Acuity Chart System HDC-100 | Huvitz Co., Ltd. | 2025-11-19 |
| B43071000030 | GoCheck MultiScreener | Gobiquity, Inc. | 2025-11-19 |
| B43050085610 | GoCheck Kids | Gobiquity, Inc. | 2025-11-04 |
| B43050085600 | GoCheck Kids | Gobiquity, Inc. | 2025-10-22 |
| 04540008310610 | Rexxam | REXXAM CO., LTD. | 2025-10-17 |
| 04540008310580 | Rexxam | REXXAM CO., LTD. | 2025-10-17 |
| B43050085500 | GoCheck Kids | Gobiquity, Inc. | 2025-03-20 |
| B43071000020 | GoCheck MultiScreener | Gobiquity, Inc. | 2024-09-23 |
| B43050085440 | GoCheck Kids | Gobiquity, Inc. | 2024-07-26 |
| 04053755120376 | LAMBDA 100 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04053755120345 | LAMBDA 100 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04053755120079 | LAMBDA 100 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04053755120055 | LAMBDA 100 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04049584010032 | Binoptometer® 4P incl. integrated electromotoric height adjustment | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2022-12-01 |
| 04049584010049 | Binoptometer 4P | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2022-12-01 |
| 04049584022011 | Vissard 3D, linear polarized | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2022-12-01 |
| 04049584022158 | Vissard 3D, circular polarized | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2022-12-01 |
| 04049584025166 | Vissard RG | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2022-12-01 |
| 08034028770326 | TOPCON | VISIA IMAGING SRL | 2022-09-15 |
| 08034028770319 | TOPCON | VISIA IMAGING SRL | 2022-09-15 |
| 03760253450171 | VT1 | FIM MEDICAL | 2017-10-17 |
| 03760253450256 | VT1 | FIM MEDICAL | 2017-10-16 |
| 03760253450225 | VT1 | FIM MEDICAL | 2017-10-16 |
| 03760253450164 | VT1 | FIM MEDICAL | 2017-10-16 |
| 03760253450140 | VT1 | FIM MEDICAL | 2017-10-16 |
| 03760253450027 | VT1 | FIM MEDICAL | 2017-10-16 |
| 04987669101414 | Tabletop Refraction System | NIDEK CO.,LTD. | 2017-07-03 |