# K240722: Derma-R Cream (Derma-R Cream)

- Pathway: 510(k) (Traditional)
- Applicant: Raya Pharmaceuticals, LLC
- Decided: Sep 20, 2024 after 186 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: 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)
- K090585: Neosalus Cream, Quinnova Pharmaceuticals (2009) Summary page 5.

## Indications for use
It is intended for management of pruritus and Dryness of skin in Atopic dermatitis and Allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores.

Source page: https://510kreport.com/device/K240722
Methodology: https://510kreport.com/methodology