510(k) Report

Devices descending from K173549

4 later devices reach Biafine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251093Bonvadis®Oneness Biotech Co., Ltd.20251—
+1K232655Bonvadis®Stemcyte, Inc.20242—
+1K190342BIAFINE Topical CreamBausch Health Americas Incorporated20190—
+2K261638Bonvadis®Oneness Biotech Co., Ltd.20260—