# K093159: PR Cream

- Pathway: 510(k) (Traditional)
- Applicant: Prugen IP Holdings, Inc.
- Decided: Jun 24, 2010 after 261 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)
- K071483: Tetrix Cream, Coria Laboratories, Ltd. (2008) Summary page 1.

## Indications for use
PRTM cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PRTM cream 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/K093159
Methodology: https://510kreport.com/methodology