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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 K201325
Device Name Optomed Smartscope M5 with Optomed Smartscope FA
Optomed Oyj
Yrttipellontie 1
Oulu,  FI 90230
Applicant Contact Jyri Leskelä
Optomed Oyj
Yrttipellontie 1
Oulu,  FI 90230
Correspondent Contact Jyri Leskelä
Regulation Number886.1120
Classification Product Code
Date Received05/18/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No