510(k) K221320
K221320 is an FDA 510(k) premarket notification submitted by Nidek Co., Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on Mar 30, 2023. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Nidek Co., Ltd. has 19 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 30, 2023
- Date Received
- May 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tomography, Optical Coherence
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type
- 510(k)
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.