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Sonoma Pharma Receives US FDA 510(k) Clearance for Microcyn-Based Wound Care Hydrogel

14 Nov 2024
Admin
News Article

Sonoma Pharma Receives US FDA 510(k) Clearance for Microcyn-Based Wound Care Hydrogel

Overview

Sonoma Pharmaceuticals, Inc., a global healthcare leader developing and producing patented Microcyn technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, announced it has received a new 510(k) clearance from the US Food and Drug Administration (FDA) for its Microcyn technology-based hydrogel, including improved biocompatibility and extended shelf life.

The Microdacyn Hydrogel: Post Clearance

Per this new clearance, Sonoma's Microdacyn hydrogel can be used under the supervision of a healthcare professional for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue, for use on first and second degree burns, and diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
It is also indicated for OTC use on minor skin irritations, lacerations, abrasions and minor burns, including for the management of irritation from sunburn.
The new 510(k) clearance process also included more rigorous biocompatibility testing, and the clearance applies to 50mL bottles with a shelf life of 24 months.

Words from the CEO: Sonoma

"This new 510(k) clearance from the FDA demonstrates the superior safety and efficacy of Sonoma's wound care products,"" said Amy Trombly, CEO of Sonoma.
"Our Microcyn technology-based hydrogel is effective for the management of both wounds and skin irritations, and we are pleased to see it has passed the more rigorous testing required by the FDA. Our commitment to innovation and the high standards we set for our products sets us apart in the industry.