Medifirst Solutions, Inc. reported that it has completed its response to the Food and Drug Administration’s (FDA) request for more information about its Time Machine TTML-8102000 laser thermal therapeutic device and that the FDA’s Center for Devices and Radiological Health now has it under review.
The company earlier had announced that it has successfully completed testing of the device with Intertek. The testing was for IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility. According to Intertek’s final EMC test report the evaluated product meets the requirements of that standard.
The infrared laser at 810/830 nm wavelength is indicated for temporary relief of minor muscle and joint pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.
This test was part of the FDA’s request for more information in response to the Medifirst filing for 510(k) clearance for its Time Machine laser series.
In anticipation of 510(k) approval, Medifirst said it is preparing for the next phase of the operation and is currently developing its national sales, marketing and social media strategy for both domestic and international sales and distribution.
Medical Lasers Manufacturer, Inc., a Medifirst subsidiary, will specialize in producing the high quality diode-pumped solid-state lasers. The division, including products and treatment programs, will focus on specific cosmetic skin conditions, relief of muscle and joint pain, and muscle spasm and inflammation.
Driven by the demand for minimally invasive skin and pain treatments, the global market for medical and therapeutic lasers was estimated by Medifirst at $4 billion in 2015.
