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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 K232417
Device Name MR Q; MR Q SUPINE; MR Q SLT
Applicant
Meridian AG
Bierigutstrasse 7
Thun,  CH CH-3608
Applicant Contact Eric Odenheimer
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/11/2023
Decision Date 01/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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