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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
510(k) Number K240616
Device Name FAQ™ (102)
Applicant
Foreo, Inc.
1525 E Pama Ln.
Las Vegas,  NV  89119
Applicant Contact Evan Feldstein
Correspondent
DD Consulting
401-4080 Living Arts Dr.
Mississauga,  CA L5B4N#
Correspondent Contact Danijela Domljanovic
Regulation Number878.4420
Classification Product Code
PAY  
Subsequent Product Codes
NFO   OHS  
Date Received03/05/2024
Decision Date 07/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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