# K110757: TL-Cermide Skin Barrier Emulsion

- Pathway: 510(k) (Traditional)
- Applicant: Trigen Laboratories, Inc.
- Decided: Aug 19, 2011 after 154 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052643: Epiceram, Ceragenix Corporation (2006) Summary page 1.

## Most influential descendants
- K152055: Ceramax Skin Barrier Cream (2015), 0 descendants of its own

## Indications for use
TL-Cermidle Skin Emulsion is 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. TL-Cermide Skin Emulsion 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/K110757
Methodology: https://510kreport.com/methodology