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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K240378
Device Name FAQ™ 201, FAQ™ 202
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 Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received02/07/2024
Decision Date 04/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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