Cleared Traditional

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 · Nidek Co., Ltd. · Ophthalmic

Mar 2023

Decision

328d

Days

Class 2

Risk

About This 510(k) Submission

K221320 is an FDA 510(k) clearance for the 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, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on March 30, 2023, 328 days after receiving the submission on May 6, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K221320 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2022
Decision Date	March 30, 2023
Days to Decision	328 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1570
Definition	Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.