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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K261565
Device Name FAQ™ (FAQ 411)
Applicant
Foreo, Inc.
1525 E Pama Ln.
Las Vegas,  NV  89119
Applicant Contact Feldstein Evan
Correspondent
DD Consulting
401-4080 Living Arts Dr.
Mississauga,  CA L5B4N#
Correspondent Contact Domljanovic Danijela
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
OLI  
Date Received05/11/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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