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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K250353
Device Name Oniris; Oniris Plus
Applicant
Oniris
147 Ave. Paul Doumer
Rueil Malmaison,  FR 92500
Applicant Contact Maria Markarova
Correspondent
Alizée Mareczko
147 Ave. Paul Doumer
Rueil Malmaison,  FR 92500
Correspondent Contact Maria Markarova
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/07/2025
Decision Date 09/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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