PETALUMA, Calif. -- Hoji Alimi, founder and president of Oculus Innovative Sciences, today announced that the company has received its first 510K clearance from the Food and Drug Administration (FDA) to market Dermacyn Wound Care, formulated with Microcyn Technology, as a medical device for moistening, lubricating and debriding of acute and traumatic wounds and burns.
Microcyn technology is a super-oxidized, pH-neutral solution that is ready for use with no dilution or mixing, and requires no special handling or disposal. It is manufactured using a sophisticated, multi-chamber electrolysis process in which ionic species are selectively produced and isolated. This process allows for the production of a pH-neutral solution while minimizing the level of chlorine in the final product.
This FDA 510K clearance as a medical device allows the company to market its label claims and enter into negotiations with distributors for commercialization purposes. Dermacyn Wound Care, the first Microcyn technology product for human use in the United States, will be available to physicians in June 2005.
The company also received CE approval according to the European Medical Devices Directive (93/42/EEC) for Dermacyn Wound Care in November of this past year. It was certified as a Class IIb medical device for treating acute and chronic wounds (e.g., diabetic foot ulcers and burns) as part of a comprehensive wound care regimen. The Microcyn Technology received approval as a disinfectant, antiseptic and sterilant from the Mexican Ministry of Health in 2003 where the product is now widely commercialized and in use for the treatment of myriad wounds and burns. Dermacyn Wound Care also received regulatory approval this past November from the Therapeutic Product Directorate, the Canadian federal authority that regulates pharmaceutical drugs and medical devices, as a dermal wound irrigant that facilitates removal of wound debris as it cleanses and debrides.
Source: Oculus Innovative Sciences
Stay prepared and protected with Infection Control Today's newsletter, delivering essential updates, best practices, and expert insights for infection preventionists.
Pathogen Pulse: Facilities Need the SPD, Yersinia Enterocolitica Outbreak, and More
July 22nd 2025From unsterilized surgical tools in Colorado to a years-long methicillin-resistant Staphylococcus aureus (MRSA) outbreak in Virginia and a surging measles crisis in Canada, recent headlines reveal the fragile front lines of infection prevention and the high stakes when systems fail.
The Next Frontier in Infection Control: AI-Driven Operating Rooms
Published: July 15th 2025 | Updated: July 15th 2025Discover how AI-powered sensors, smart surveillance, and advanced analytics are revolutionizing infection prevention in the OR. Herman DeBoard, PhD, discusses how these technologies safeguard sterile fields, reduce SSIs, and help hospitals balance operational efficiency with patient safety.
Breaking the Cycle of Silence: Why Sharps Injuries Go Unreported and What Can Be Done
Published: July 24th 2025 | Updated: July 23rd 2025Despite decades of progress in health care safety, a quiet but dangerous culture still lingers: many health care workers remain afraid to report sharps injuries, fearing blame more than the wound itself.
Back to Basics: Hospital Restores Catheter-Associated UTI Rates to Prepandemic Baseline
June 16th 2025A 758-bed quaternary medical center slashed catheter-associated urinary tract infections (CAUTIs) by 45% over 2 years, proving that disciplined adherence to fundamental prevention steps, not expensive add-ons, can reverse the pandemic-era spike in device-related harm.
Beyond the Surface: Tackling the Sterilization Challenges of Flexible Endoscopes
May 26th 2025Flexible endoscopes revolutionized modern medicine—but their complex design poses persistent sterilization challenges. With mounting infection risks and emerging innovations, experts are rethinking how to clean and safeguard one of health care’s most indispensable tools.