Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
FDA 510(k) K221320 · Nidek Co., Ltd.
510(k) numberK221320
Submission
- Device name
- Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
- Applicant
- Nidek Co., Ltd.
Gamagori, JP - Received
- May 6, 2022
- Decision date
- March 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBO – Tomography, Optical Coherence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
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|---|---|---|---|
| K261019 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 09/11/2026SE |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 05/07/2026SE |
| K252633 | Unity DX (Udx)OBO · Traditional | Cylite Pty. , Ltd. | 12/23/2025SE |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional | Tomey Corporation | 07/18/2025SE |
| K250868 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 05/12/2025SE |
| K240924 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 12/13/2024SE |
| K241163 | SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 10/11/2024SE |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional | Topcon Corporation | 07/17/2024SE |
| K240221 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 07/01/2024SE |
| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | Carl Zeiss Meditec, Inc. | 05/17/2024SE |
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| K181345 | Image Filing Software NAVIS-EXNFJ · Traditional | 07/19/2018SE |
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| K170302 | Yellow Laser Photocoagulator YLC-500HQF · Traditional | 06/23/2017SE |
| K163564 | Slit Lamp SL-2000HJO · Traditional | 05/19/2017SE |
| K152729 | Microperimeter MP-3HKI · Traditional | 06/06/2016SE |
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Questions and answers
When was Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX cleared by the FDA?
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (K221320) received a 510(k) decision of Substantially Equivalent on March 30, 2023, 328 days after the submission was received.
What is the product code of K221320?
The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.