# K083024: Hylatopic Emollient Foam

- Pathway: 510(k) (Traditional)
- Applicant: Collegium Pharmaceutical Incorporated
- Decided: Mar 27, 2009 after 169 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: 4 generations back to K961758 (1996). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 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 2.
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 2.
- K060272: Locobase Wound and Skin Emulsion, Ferndale Laboratories, Inc. (2007) Summary page 2.

## Most influential descendants
- K093051: Hylatopic Plus Emollient Foam (2009), 6 descendants of its own
- K110727: Hylatopicplus Cream (2011), 4 descendants of its own
- K113774: HPR Plus Emollient Foam (2012), 1 descendant of its own
- K150914: Dash-Topic Plus Cream (2016), 0 descendants of its own
- K132329: Nivatopic Plus (2013), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, HylatopicTM Emollient Foam, an aerosol-based emollient foam, is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicTM Emollient Foam also helps 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/K083024
Methodology: https://510kreport.com/methodology