FDA 510(k) K242382, décoLITE LED Device, by iSMART Developments, Ltd.
FDA 510(k) K242382, décoLITE LED Device, by iSMART Developments, Ltd.
Device Classification Name: Light Based Over The Counter Wrinkle Reduction
510(k) Number: K242382
Device Name: décoLITE LED Device
Applicant: iSMART Developments, Ltd.
Regulation Number: 878.481
Classification Product Code: OHS
Date Received: 2024-08-12
Decision Date: 2024-11-08
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery
Total number of pages: 1,295
Fully redacted pages: 1,065
Content pages: 230
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