Class 4 Laser Based Medical Devices

FDA-Compliant Class 4 Medical Laser Manufacturing

Among the most impressive technological advancements of the past several decades is the development and refinement of lasers for medical use. Cogmedix is widely acknowledged as an industry leader in the manufacturing of laser-based medical devices. A breadth of expertise in building products that incorporate laser technology is one of the many critical factors that differentiate the company from others in the industry. Cogmedix applies comprehensive knowledge and experience to the manufacturing and testing process of optical and laser-based medical devices, ensuring a successful launch and a strong position in the marketplace for each of its customers.

Laser Classification

There are four distinct classes of lasers. While Class 1, Class 2, and Class 3 lasers are also well within the company’s proven scope of expertise, Cogmedix deals most often with Class 4 lasers, categorized as the most powerful of the four classes. This class includes lasers (visible or invisible) presenting potential acute hazard to the eye and skin for both direct (intrabeam) and scatter (diffused) conditions, potential hazard considerations for fire (ignition), and by-product emissions from target or process materials. Understandably, manufacturing any product containing a Class 4 laser requires specific safety and environmental conditions.

Regulatory Compliance

Cogmedix operates a registered Class 4 laser facility compliant with the requirements of American National Standards Institute Z136 Guidelines and 105 CMR 121.000. Through a formal laser safety training program, all Caring Associates are well-versed in the necessary regulations and procedures involved in each stage of the manufacturing process. The company has manufactured a vast array of products containing Class 4 lasers, including manufacturing custom laser chambers, and provides expert assembly, integration, and testing as a vital part of the manufacturing process. This thorough approach is invaluable when bringing a product safely to market in the most compliant, efficient, and cost-effective manner.

Applications for Laser-Based Medical Devices

Laser-based medical devices are commonly used in cosmetic, surgical, ophthalmological, dental, imaging, and diagnostic procedures. The state-of-the-art devices designed by innovative OEM’s and manufactured by Cogmedix have revolutionized medical care. Healthcare professionals now have access to the tools they need to perform light-based medical treatments safely and consistently.

Click here to find out how Cogmedix can help bring your laser-based medical device to market.