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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K180378
Device Name Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Optomed Oy
Yrttipellontie 1
Oulu,  FI 90230
Applicant Contact Jyri Leskela
Optomed Oy
Yrttipellontie 1
Oulu,  FI 90230
Correspondent Contact Jyri Leskela
Regulation Number886.1120
Classification Product Code
Date Received02/12/2018
Decision Date 04/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No