Product code HJL
- Device name
- Lens, Condensing, Diagnostic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1380
- 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 |
|---|---|---|---|
| K790526 | LIO-714 OPACITYMETER | Laser Industries , Ltd. | 1979-11-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 00811608019871 | SuperField® Limited Edition #2 | VOLK OPTICAL INC. | 2025-08-01 |
| 00811608019864 | Super 66® Limited Edition #2 | VOLK OPTICAL INC. | 2025-08-01 |
| 00811608019857 | 90D Limited Edition #2 | VOLK OPTICAL INC. | 2025-08-01 |
| 00811608019840 | 78D Limited Edition #2 | VOLK OPTICAL INC. | 2025-08-01 |
| 00811608019833 | Pan Retinal 2.2 Limited Edition #2 | VOLK OPTICAL INC. | 2025-08-01 |
| 00811608019819 | 20D Limited Edition #2 | VOLK OPTICAL INC. | 2025-08-01 |
| 00811608019826 | 28D Limited Edition #2 | VOLK OPTICAL INC. | 2025-08-01 |
| 00811608014838 | SuperField® Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608014821 | Super 66® Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608014814 | 90D Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608014807 | 78D Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608014791 | Digital ClearField Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608014784 | Pan Retinal 2.2 Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608014777 | 28D Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608014760 | 20D Limited Edition | VOLK OPTICAL INC. | 2024-09-26 |
| 00811608013787 | SuperField® NC, Custom Color | VOLK OPTICAL INC. | 2023-01-06 |
| 04053755117420 | OPHTHALMOSCOPY LENS A.R. | Heine Optotechnik GmbH & Co. KG | 2022-12-15 |
| 04053755117390 | OPHTHALMOSCOPY LENS A.R. | Heine Optotechnik GmbH & Co. KG | 2022-12-15 |
| 04053755117369 | OPHTHALMOSCOPY LENS A.R. | Heine Optotechnik GmbH & Co. KG | 2022-12-15 |
| 00852475007165 | HD Disposable, LenZ | OCULUS SURGICAL INC | 2022-02-15 |
| 00852475007141 | BIOM Optic Set, HD Professional, for f=200mm | OCULUS SURGICAL INC | 2022-02-15 |
| 00852475007127 | BIOM Optic Set, HD Professional, for f=175mm | OCULUS SURGICAL INC | 2022-02-15 |
| 00852475007240 | Versa Optic Set, for f=200mm | OCULUS SURGICAL INC | 2022-01-25 |
| 00852475007264 | VERSA HD Disposable LenZ | OCULUS SURGICAL INC | 2020-12-04 |
| 00856222004544 | SUPER VIEW® Disposable HD Lens Set for RESIGHT® | OCULUS SURGICAL INC | 2020-11-24 |
| 00811608018973 | Single Use 28D | VOLK OPTICAL INC. | 2020-09-24 |
| 00856222004742 | SUPER VIEW® Disposable Lens Set, Pivot | OCULUS SURGICAL INC | 2016-09-23 |
| 00856222004650 | SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT® | INSIGHT INSTRUMENTS, INC. | 2016-09-23 |
| 00856222004056 | SUPER VIEW® Disposable Lens Set, Essential | OCULUS SURGICAL INC | 2016-09-23 |