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510(k) Data Aggregation
K Number
K061849Device Name
MESODERM
Manufacturer
Date Cleared
2007-04-30
(304 days)
Product Code
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
AA ADVANCED TECHNOLOGY INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MesoDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
Device Description
MesoDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. It has a dispersive electrode, which is attached to the microprocessor. An FDA approved conductive grounding pad is also required prior to its use. Introducing ions can be accomplished with MesoDerm's Dispensing Electrode and roller using methods described in the operator's manual. This is accomplished as the roller conducts current to the skin via the product to be delivered. The product has a positive charge, the current coming into the roller has a positive charge and when they meet the product the ions are diffused into the skin.
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