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510(k) Data Aggregation
K Number
K231952Device Name
MEDILIGHTManufacturer
Date Cleared
2025-09-03
(796 days)
Product Code
Regulation Number
878.4810Type
SpecialReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The MediLight device (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
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AI/ML Overview
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