# K152055: Ceramax Skin Barrier Cream

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences
- Decided: Nov 23, 2015 after 122 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961758 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
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 4.
- K110757: TL-Cermide Skin Barrier Emulsion, Trigen Laboratories, Inc. (2011) Summary page 4.

## Recalls of this device
- Nov 21, 2016 · Class II · Z-0763-2017: Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.

## Indications for use
Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K152055
Methodology: https://510kreport.com/methodology