FDA Representatives Visit Thunder Laser to Review Production and Laser Safety
2016-07-17WHAT ARE YOU LOOKING FOR?
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2016-07-17
On July 21, representatives from the United States Food and Drug Administration visited Thunder Laser. The visitors included Mr. Emir Galevi, Electronics Engineer and Laser Expert, and Mr. Patrick Hintz, Magnetic Resonance and Electronic Products Branch Chief.
Thunder Laser General Manager King Chen, Vice General Manager Ken Chen, Technical Manager Tom, and VIP Manager Amy attended the meeting with Mr. Emir and Mr. Patrick. The visit focused on Thunder Laser’s business development in the United States, production management, quality testing, and laser safety.
Reviewing Thunder Laser’s U.S. Market Development
During the meeting, Amy presented a detailed report on Thunder Laser’s business development in the U.S. market. According to the report, since 2012, Thunder Laser had maintained more than 60% growth in the U.S. market.
With this growth, Thunder Laser placed greater focus on improving machine safety and functions to meet U.S. government requirements. Amy also presented Mr. Patrick Hintz with Thunder Laser’s FDA reports, U.S. shipping records, and related application materials from previous years.
Production Line and Quality Testing Review
Accompanied by General Manager King Chen, the two FDA representatives visited Thunder Laser’s production line, including the mechanical assembly line, electrical assembly line, and laser quality testing line.
During the visit, they checked testing instruments, calibration records, labels, and other production-related materials. Technical Manager Tom also explained the detailed production process and discussed mechanical details and laser safety with Mr. Emir Galevi.
NOVA Series Laser System Safety Features
Tom also introduced the NOVA series laser system to the visitors. The NOVA series was designed with dual safety channel control, an independent safety logic center, and energy-saving control.
These safety-focused designs help improve machine safety and support the requirements of European and U.S. markets. According to the original visit record, Mr. Emir and Mr. Patrick confirmed that the NOVA laser systems had reached the Class 1 laser product standard under FDA rules.
This visit reflected Thunder Laser’s continued attention to laser safety, quality testing, production records, and international market compliance.
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