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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 K212947
Device Name Trinity Plus Wrinkle Reducer
Applicant
Carol Cole Company dba NuFACE
1325 Sycamore Ave, Suite A
Vista,  CA  92081
Applicant Contact David Reece
Correspondent
Bob Duffy Associates, Inc.
16405 Summer Sage Rd.
Poway,  CA  92064
Correspondent Contact Bob Duffy
Regulation Number878.4810
Classification Product Code
OHS  
Date Received09/15/2021
Decision Date 04/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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