# K041342: Impruv a.I. Cream Wound and Skin Emulsion

- Pathway: 510(k) (Traditional)
- Applicant: Stiefel Laboratories, Inc.
- Decided: Jul 19, 2005 after 425 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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: 2 generations back to K961758 (1996). 3 ancestors in all.
44 later devices descend from it; 17 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.
- K024367: Sinclair Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.

## Most influential descendants
- K052643: Epiceram (2006), 16 descendants of its own
- K060272: Locobase Wound and Skin Emulsion (2007), 10 descendants of its own
- K083024: Hylatopic Emollient Foam (2009), 8 descendants of its own
- K073246: Zenieva (2008), 7 descendants of its own
- K093051: Hylatopic Plus Emollient Foam (2009), 6 descendants of its own

## Indications for use
FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, MimyX Cream is indicated to manage and relieve the burning and itching experienced with various-types of denmatoses, including radiation dermatitis, atopic dennatitis and allergic contact dermatitis. MirnyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Directions for Use (Rx and OTC): Apply MimyX Cream to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover MimyX Cream with a dressing of choice. Description OTC Product: MirnyX Cream helps to nourish skin and relieve theburning and itching associated with many common types of skin irritation. MimyX Cream may also be used to soothe minor bums, including sunburn.

Source page: https://510kreport.com/device/K041342
Methodology: https://510kreport.com/methodology