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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 K260598
Device Name 5 Wavelength LED Facemask (TN2508)
Applicant
iSMART Developments, Ltd.
129 Green Ln.S, Wylde Green
Birmingham,  GB B73 5LT
Applicant Contact Susan D'Arcy
Correspondent
iSMART Consulting, LLC
3495 W Kamran Ridge Cv
South Jordan,  UT  84095
Correspondent Contact Steve Baker
Regulation Number878.4810
Classification Product Code
OHS  
Date Received02/24/2026
Decision Date 07/24/2026
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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