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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 K201623
Device Name LION Photocoagulator
Applicant
Norlase Aps
Brydehusvej 30
2750 Ballerup,  DK
Applicant Contact Jan Forstberg
Correspondent
Sheila Pickering Consulting Group
2081 Longden Circle
Los Altos,  CA  94024
Correspondent Contact Sheila Pickering
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received06/15/2020
Decision Date 08/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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