Fonon Technologies Announces Family of FDA Compliant UDI Medical Marking Systems



PRESS RELEASE
March 23, 2015

Fonon Technologies Announces Family of FDA Compliant Unique Device Identification (UDI) Marking Systems for Medical Device Applications

Fonon Technologies’ LaserTower™ Family of UDI Marking Systems supports a wide range of Medical Device Manufacturing Applications from Stand-Alone Workshop Models to High-Volume Systems that Easily Integrate into Existing I/0 Production Lines 

Lake Mary, FL – Fonon Technologies (“Fonon”), a pioneer in next-generation 3D Fiber and CO2 Material Processing Systems, announces its LaserTower™ family of FDA compliant permanent UDI marking systems for medical device manufacturers.  Fonon’ family of industrial-grade LaserTower™ Systems are optimized for each customer based on the unique requirements of their application.  They are the most flexible 3D Laser-based marking and engraving systems in the industry as each system can be configured with either a Fiber or CO2 laser with wattage options from 10W to 100W.

Late last year, the FDA mandated a requirement that medical facilities provide UDI traceability of high-risk medical devices as part of their reporting process related to patient death.  Approximately 50,000 serious adverse events directly related to medical devices are reported to the FDA each year, including up to 3,000 deaths.  By utilizing FDA compliant marking systems like those produced by Fonon, patient-safety advocates forecast reductions in medical errors, improvements in product registries and more effective fast-track medical product recalls.

Medical device manufacturers and medical facilities must implement UDI coding on all Class III (high-risk) devices by September 2015 with a seven year rollout plan for the rest of the medical device industry.

Fonon’s family of LaserTower™  UDI Marking Systems address all possible UDI medical device production operations from stand-alone desktop models to large-volume throughput systems that can easily be integrated into existing production lines.  In addition, Fonon is the only company to offer a portable Fiber Laser Hand-Held UDI marking system for applications that are too large to fit into conventional processing chambers.

Fonon’s LaserTower™ Marking Systems are designed to support all UDI-required medical device materials including highly reflective metals.  Aluminum, Stainless-Steel, Nickel and Titanium are examples of highly reflective metals that require the end-user to adjust the barcode scanning angle to avoid specular reflection in order to detect the UDI marking.  By adjusting the angle of incidence in the range of 5 degrees to 30 degrees, the barcode scanner receives an optimum irregular reflection resulting in positive detection of the 2D matrix code.  A 2D Camera Barcode Scanner is also highly recommended as this system can hold and provide much more data than standard barcode readers and allows optimum reading of UDI marks on highly-reflective metals.

For more information, please contact Robert Hunt at: rhunt@fonon.us, or 844-44-LASER (52737).

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About Fonon   
Fonon is the industry leader in developing high-tech fiber and CO₂ laser systems for marking, cutting, 3D Printing and 3D engraving and Zero Width Laser Cutting Technologies™ applications. Our systems are used by manufacturers in the semiconductor, flat panel display, automotive, aerospace, industrial, defense, electronic and medical industries around the world.  Fonon is the recognized leader of industrial grade 3D Additive and 3D Subtractive laser-based material processing systems. We offer cutting-edge Additive Manufacturing Solutions for 3D Metal Printing Systems based on Direct Metal Laser Sintering (DMLS) and Subtractive Manufacturing Solutions for 3D Marking, Engraving and Cutting Systems including our patented Zero Width laser Cutting Technologies™. Our systems are used world-wide in the semiconductor, flat panel display, automotive, aerospace, industrial, defense, electronic and medical industries with a portfolio of intellectual property, knowhow & inventions placing our company in the unique position to offer both standard 3D material processing systems or our specialty of tooling 3D laser-based transforming systems designed around the unique applications of our customers.

Notice Regarding Forward-Looking Statements:
Statements regarding financial matters in this press release other than historical facts are “forward-looking statements” (“FLS”) within the meaning of section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. FLS include statements predictive in nature, depending upon or referring to future events / conditions, including words like “believes,” “anticipates,” “intends,” “plans,” “expects,” and similar expressions. Statements concerning future financial performance (revenues, earnings, and growth rates), ongoing business strategies / prospects, and future actions, which may be provided by management, are also FLS as defined by the Act. The actual and any future results, performance or achievements of the Company, expressed or implied, may be materially different and vary significantly for different reporting periods due to FLS that involve known and unknown risks and other factors. Management believes that the assumptions made and expectations reflected in the FLS are reasonable. There is no assurance that the underlying assumptions will prove to be correct and the actual future results may be different from expectations expressed above. These statements are not guarantees of future performance. Fonon Technologies has no specific intention to update these statements.




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