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Re: RuffNStuff post# 14012

Monday, 08/01/2016 2:36:28 AM

Monday, August 01, 2016 2:36:28 AM

Post# of 37663
INFRARED LASER 810/830 EXPECT FOR ANOTHER FDA CLEARANCE-APPROVAL

The Infrared Laser 810/830nm is ideally utilized to provide temporary relief of minor muscle, joint pain and muscle spasm. It
temporary increases local blood circulation and therefore a
relaxation of muscles.
–HAND-HELD
–MOBILE
–EASY-TO-USE
–IMMEDIATE RESULTS
–AFFORDABLE
–RECHARGEABLE
–NON-INVASIVE
–NO DOWNTIME

Medifirst Solutions 510(k) Submission Accepted by the FDA

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.



https://www.mdtmag.com/news/2016/06/medifirst-solutions-510k-submission-accepted-fda

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