FDA 510(k) Applications Submitted by Tsutomu Sunada

FDA 510(k) Number Submission Date Device Name Applicant
K221320 05/06/2022 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 Nidek Co., LTD.
K192045 07/31/2019 Ophthalmic Yag Laser System YC-200 Nidek Co., Ltd.
K203130 10/19/2020 Ophthalmic Yag Laser System YC-200 Nidek Co., Ltd.


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