Clearance Summary
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 received FDA 510(k) clearance under submission number K221320, sponsored by Nidek Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2023-03-30.
- Submission: K221320
- Applicant / Sponsor: Nidek Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2023-03-30
Classification & Regulation
This clearance is catalogued under FDA product code OBO and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.