# K173549: Biafine

- Pathway: 510(k) (Traditional)
- Applicant: Valeant Pharmaceuticals
- Decided: Aug 13, 2018 after 270 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: 6 generations back to K830708 (1983). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 4.
- K153648: Microcyn Plus Skin and Wound Hydrogel, Oculus Innovative Sciences (2016) Summary page 4.
- K090092: Sockit! and Mcmerlin Dermal Wound Gel, Mcmerlin Dental Products LP (2009) Summary page 4.

## Most influential descendants
- K232655: Bonvadis® (2024), 2 descendants of its own
- K251093: Bonvadis® (2025), 1 descendant of its own
- K261638: Bonvadis® (2026), 0 descendants of its own
- K190342: BIAFINE Topical Cream (2019), 0 descendants of its own

## Indications for use
OTC Indications and Usage: BIAFINE 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 may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns. RX Indications and Usage: BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns. BIAFINE 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/K173549
Methodology: https://510kreport.com/methodology