Sonoma Pharmaceuticals Receives FDA Clearance for Microdacyn Wound Irrigation Solution
Sonoma Pharmaceuticals has received a new 510(k) clearance from the U.S. Food and Drug Administration for its Microdacyn Wound Irrigation Solution, including expanded claims, clearance for multiple use, and additional packaging configurations. Under this new clearance, Microdacyn Wound Irrigation Solution can be used under the supervision of a healthcare professional for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms from exudating and/or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and partial thickness second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites, and for moistening and lubricating absorbent wound dressings. Microdacyn Wound Irrigation Solution can also be used for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes. The new 510(k) clearance expands the use case to single patient, multiple use. The 510(k) also adds new packaging configurations, including 4 oz, 8 oz, 16 oz, and 34 oz PET bottles with a polypropylene flip-top cap, and a 4 oz PET bottle with polypropylene sprayer or spray gun, each with a 24-month shelf life.
