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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K221320
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.
34-14 Maehama, Hiroishi-Cho
Gamagori,  JP 443-0038
Applicant Contact Tsutomu Sunada
Correspondent
Ora, Inc.
300 Brickstone Sq.
Andover,  MA  01810
Correspondent Contact Ryan Bouchard
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Codes
MYC   NFJ  
Date Received05/06/2022
Decision Date 03/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT04318132
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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