On July 21st，The Department of Health and Human Services United States Food and Drug AdministrationWinchester Engineering and Analytical Center (FDA in short) sent Electronics Engineer & Laser Expert Mr Emir Galevi, and Magnetic Resonance and Electronic Products Branch Chief Mr Patrick Hintz to our company for visit. Our General Manager King Chen, Vice-General Manager Ken Chen, Technical Manager Tom and VIP Manager Amy participated in the meeting with Mr. Emir and Mr. Patrick.
Amy made a detail report and presentation of our business development in USA. Since 2012, our company kepta more than 60% growth in US market. Withsuch a rapid growth, our company will pay more attention to improving the machinery safety and functions to meet US government requirement. Later, Amy alsopresentedMr Patrick Hintz (the Magnetic Resonance and Electronic Products Branch Chief) with all of our FDA report and USA shipping records and applying rules in the past years.
Accompanied by our General Manager King Chen, the two FDA experts visited our Production line including mechanical assembly production line and electrical assembly line, Laserquality testing line and checked Testing instruments, Calibration records and Labels, etc. Our technical manager Tom accompanied to give some interpretation of the detail production process, and made a deep discussion with Mr.EmirGalevi about mechanical details and laser safety.
Tom also introduced our new product- the NOVA serieslaser system to them.The NOVA series are designedwith dual safety channel control, independent safety logic center and energy saving control, all of these help toupgrade the machine safety to a higher level to meet European and US market requirement.
At last, both Mr. Emir and MrPartrick confirmed that our Nova laser systemshave reached Class 1 laser product standard under FDA ruler.