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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
Applicant
Optomed Oyj
Yrttipellontie 1
Oulu,  FI 90230
Applicant Contact Jyri Leskelä
Correspondent
Optomed Oyj
Yrttipellontie 1
Oulu,  FI 90230
Correspondent Contact Jyri Leskelä
Regulation Number886.1120
Classification Product Code
HKI  
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
Predetermined Change
Control Plan Authorized		 No
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