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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 K261473
Device Name Chromix
Applicant
Termosalud S.L.
Ataulfo Friera Tarfe 8
Gijon,  ES 33211
Applicant Contact Cristina Cifuentes
Correspondent
Hoy & Associates Regulatory Consulting, LLC
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Connie Hoy
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received05/04/2026
Decision Date 07/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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