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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
510(k) Number K243729
Device Name Prismira
Applicant
Lumos Labs, Inc.
16 Maiden Lane
Ste 600
San Francisco,  CA  94108
Applicant Contact Robert (Bob) Schafer
Correspondent
Aepis Medical
6320 Mitchell Rd.
Shingle Springs,  CA  95682
Correspondent Contact Adam Savakus
Regulation Number882.5803
Classification Product Code
QFT  
Date Received12/03/2024
Decision Date 06/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
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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