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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K222157
Device Name ECHO Photocoagulator
Applicant
Norlase
Brydehusvej 13
Ballerup,  DK DK-2750
Applicant Contact Jan Forstberg
Correspondent
Norlase
Brydehusvej 13
Ballerup,  DK DK-2750
Correspondent Contact Jan Forstberg
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/20/2022
Decision Date 10/11/2022
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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