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The Microwave Medical Corporation, Microwave Delivery System (Model MMC-300) is designed for the removal of unwanted body hair except on facial areas. This device is not for use on facial areas. Clinical data to date is not sufficient to demonstrate safety or effectiveness on facial areas.

Microwave Delivery System (MDS), Model MMC-300

This document is a 510(k) premarket notification decision letter from the FDA. It approves a device for market but does not contain a detailed study report with acceptance criteria and specific performance metrics. Therefore, I cannot extract the requested information.

The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device..."

This indicates that the device was approved based on its substantial equivalence to a legally marketed predicate device, rather than through a detailed study proving it meets specific, predefined acceptance criteria that are reported in this document. The "Indications For Use" section explicitly states: "Clinical data to date is not sufficient to demonstrate safety or effectiveness on facial areas." This further confirms the absence of detailed efficacy or safety study results in this particular approval letter.

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