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510(k) Data Aggregation
K Number
K251093Device Name
Bonvadis®
Manufacturer
Oneness Biotech Co., Ltd.
Date Cleared
2025-06-09
(60 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Oneness Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.
Device Description
Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses.
Bonvadis® is multiple use and supplied in a 15 g aluminum tube.
The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.
Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.
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