PES is the manufacturer of Sterile Eye Spheres and Conformers. Our products are distributed exclusively by Gulden Ophthalmics. Eye spheres and conformers are made from polymethylmethacrylate (PMMA) and are gamma sterilized. Please visit Gulden Ophthalmics' website for more information (www.guldenophthalmics.com)
PES is solely responsible for the design and development of these sterile devices and for obtaining the FDA clearance to distribute these Class II products. PES has the knowledge and experience to ensure the design of the medical device is in compliance with the FDA regulations and with ISO 13485. PES has also obtained clearance for a line of mobile suction pumps that are no longer in distribution.
PES has experience in the design and development of neonatal and adult respirators, anesthesia gas machines, high precision flow meters, and table top sterilizers. Additionally, PES has verified and validated computer system used in medical devices and in large pharmaceutical clinical trials.
We are actively seeking partners to design and develop medical devices for sale in the United States and worldwide. Please contact us for more information.