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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
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