Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX +1 more— 510(k) K221320

Name: FDA 510(k) clearance K221320
Creator: U.S. Food and Drug Administration
Published: 2023-03-30

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K221320 for Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX +1 more, Substantially Equivalent on 2023-03-30. Applicant: Nidek Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: 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.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2022-05-06
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamagori, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.