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MesoDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.

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.

This document is a 510(k) summary for the MesoDerm iontophoresis device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices (K032968 & K042590 Transderm® System) based on functional and technical specifications.

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The document provides the following:

• Device Description: MesoDerm is a microprocessor-controlled iontophoresis drug delivery system.
• Intended Use: Administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
• Technical Specifications: Operating Voltage, Assimilation, Standards Met, Fuses, Operating Temperature, Weight, Material Chassis, Electronics, Exit Channels.
• Substantial Equivalence Chart (Table 12.1): Compares MesoDerm to the Transderm® System across parameters like Indications for Use, Power Supply, Average Pulse Current, Load Impedance, Pulse Frequency, Burst Time, Burst Frequency, Dispenser Head, and Generator.
• Contraindications, Warnings, and Precautions.
• Product Specifications: Roll on Ball (material, diameter, sphericity) and Conductive Grounding Plate (material).
• Conclusion: The device is substantially equivalent to K032968 & K042590.
• Correspondence: A letter from consultants modifying the 510(k) to remove references to a stylus and specific default treatment times.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

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