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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Virtual Reality Behavioral Therapy Device For Pain Relief
510(k) Number K230825
Device Name Smileyscope System (Therapy Mode)
Applicant
Smileyscope Holding Inc.
701 Tillery Street #12
Austin,  TX  78702
Applicant Contact Paul Leong
Correspondent
Smileyscope Holding Inc.
701 Tillery Street #12
Austin,  TX  78702
Correspondent Contact Paul Leong
Regulation Number890.5800
Classification Product Code
QRA  
Date Received03/24/2023
Decision Date 09/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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