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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K261638
Device Name Bonvadis®
Applicant
Oneness Biotech Co., Ltd.
35f, #66, # 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist.,
Taipei,  TW 100
Applicant Contact Angel Hsieh
Correspondent
Oneness Biotech Co., Ltd.
35f, #66, # 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist.,
Taipei,  TW 100
Correspondent Contact Angel Hsieh
Classification Product Code
FRO  
Date Received05/18/2026
Decision Date 06/17/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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