# K171191: Hexagen Derm

- Pathway: 510(k) (Traditional)
- Applicant: Global Health Solutions, LLC
- Decided: Aug 25, 2017 after 123 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: 4 generations back to K961758 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160872: PolyPlex Wound Dressing, Global Health Solutions, LLC (2016) Summary page 4.
- K052643: Epiceram, Ceragenix Corporation (2006) Summary page 4.

## Indications for use
Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Hexagen Derm helps to relieve dry skin conditions and manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Hexagen Derm helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K171191
Methodology: https://510kreport.com/methodology