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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 K242382
Device Name décoLITE LED Device
Applicant
iSMART Developments, Ltd.
129 Green Ln.s, Wylde Green
Birmingham,  GB B73 5LT
Applicant Contact Susan D'Arcy
Correspondent
iSMART Developments, Ltd.
129 Green Ln.s, Wylde Green
Birmingham,  GB B73 5LT
Correspondent Contact Susan D'Arcy
Regulation Number878.4810
Classification Product Code
OHS  
Date Received08/12/2024
Decision Date 11/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT06542341
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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