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510(k) Data Aggregation
K Number
K152436Device Name
Suntanning LampsManufacturer
Date Cleared
2015-12-07
(102 days)
Product Code
Regulation Number
878.4635Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Suntanning Lamps used to tan the skin
Device Description
Not Found
AI/ML Overview
This FDA 510(k) clearance letter for "Suntanning Lamps" (K152436) does not contain any information about acceptance criteria, device performance, or any studies conducted.
The document is a standard clearance letter stating that the device is substantially equivalent to a predicate device and outlining regulatory responsibilities. It does not include data from performance testing or clinical studies.
Therefore, I cannot provide the requested information based on this document.
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