# K092297: Eletone Cream

- Pathway: 510(k) (Traditional)
- Applicant: Ferndale Pharma Group, Inc.
- Decided: Oct 9, 2009 after 72 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024367: Sinclair Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 1.
- K060272: Locobase Wound and Skin Emulsion, Ferndale Laboratories, Inc. (2007) Summary page 1.

## Indications for use
Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis (post-radiation treatment).

Source page: https://510kreport.com/device/K092297
Methodology: https://510kreport.com/methodology