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General Surgery

Precision Optical Fiber Solutions for Modern Surgical Demands

A wide and varied array of conditions and operative scenarios are presented to a general surgeon in daily practice. In addition, a wide variety of light sources, wavelengths, and laser delivery systems are used in general surgery to cut, coagulate, vaporize or remove tissue. With over 20 years of experience designing and manufacturing specialty optical fibers, Lightera has the production history, process control, and insight to design and manufacture optical fiber, cable and assemblies to exact performance and product specifications.

Lightera Delivers Biocompatible, Traceable, and Sterilizable Fiber Solutions for Medical Devices

Biocompatibility

Our medical products meet ISO 10993 and USP Class VI standards for nontoxicity and biocompatibility. Many are also already certified as biocompatible by NAMSA, and we work with our customers to qualify other fibers to these standards where needed. For the assembly stage, we maintain, test, monitor, and control a low-bioburden room for medical assembly and packaging.

Traceability

Upon customer request, Lightera is equipped to provide Device Master Records, maintain Device History Records, and adhere to other components of FDA Current Good Manufacturing Practices.

Sterilization

Most Lightera medical fibers are biocompatible and sterilizable. These can also be cabled, tubed, terminated, and assembled into higher-end components. ETO (Ethylene Trioxide) method is preferred. Autoclave is also recommended. We do not recommend gamma radiation sterilization, as this method can damage the fiber. We also offer sterilizable fibers for disposable use. Lightera is equipped to follow managed sterilization protocols for prepackaged devices. NOTE: Although Lightera provides sterilization service as an option and many of our fibers are certified as biocompatible, it is the customer’s responsibility to test all finished medical assemblies for biocompatibility and to recommend the sterilization procedure for their devices.

Discover the Lightera Advantage Today

Lightera is proud to serve the unique needs of the medical industry. We are constantly innovating to meet the demands of this market. Need help finding the right product for your application, or interested in a customized solution? Reach out to Lightera today.