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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K260360
Device Name AesyBite Active
Applicant
Aesyra SA
Epfl Innovation Park, Bat. C
Lausanne,  CH 1015
Applicant Contact Marco Letizia
Correspondent
Aesyra SA
Epfl Innovation Park, Bat. C
Lausanne,  CH 1015
Correspondent Contact Marco Letizia
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Codes
MQC   PLC  
Date Received02/04/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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