Product code HLG
- Device name
- Pupillometer, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1700
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
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|---|---|---|---|
| 03615020000397 | Digital C.R.P | ESSILOR INTERNATIONAL | 2026-04-09 |
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| 00850010118093 | NeurOptics | Neuroptics, Inc. | 2024-03-11 |
| 00850010118109 | NeurOptics | Neuroptics, Inc. | 2024-03-11 |
| 00850010118116 | NeurOptics | Neuroptics, Inc. | 2024-03-11 |
| 00850010118123 | NeurOptics | Neuroptics, Inc. | 2024-03-11 |
| 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 |
| 03665023000627 | NL-2-DEM | IDMED | 2022-06-10 |
| 00857901006453 | RETeval™ | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00857901006392 | UTAS | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00857901006460 | RETeval™ | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00857901006477 | RETeval™ | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00857901006446 | RETeval™ | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00857901006439 | RETeval™ | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00857901006415 | UTAS | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00850010118000 | NeurOptics | Neuroptics, Inc. | 2021-04-06 |
| 00850010118017 | NeurOptics | Neuroptics, Inc. | 2021-04-06 |
| 00850010118062 | NeurOptics | Neuroptics, Inc. | 2021-04-06 |
| 00850010118079 | NeurOptics | Neuroptics, Inc. | 2020-10-27 |
| 10850010118038 | NeurOptics | Neuroptics, Inc. | 2020-10-27 |
| 03665023000184 | NL-2 | IDMED | 2020-01-24 |
| 03665023000191 | NL-MU | IDMED | 2020-01-24 |
| 03665023000429 | STA-W2 | IDMED | 2020-01-24 |
| 00857901006019 | RETeval™ | L K C TECHNOLOGIES, INC. | 2016-03-11 |