# K190342: BIAFINE Topical Cream

- Pathway: 510(k) (Traditional)
- Applicant: Bausch Health Americas Incorporated
- Decided: Oct 18, 2019 after 246 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K830708 (1983). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173549: Biafine, Valeant Pharmaceuticals (2018) Summary page 4.

## Indications for use
OTC Indications and Usage: BIAFINE Topical Cream is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non-ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE Topical Cream may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.

Source page: https://510kreport.com/device/K190342
Methodology: https://510kreport.com/methodology