# K093051: Hylatopic Plus Emollient Foam

- Pathway: 510(k) (Traditional)
- Applicant: Collegium Pharmaceutical Incorporated
- Decided: Dec 7, 2009 after 68 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). 7 ancestors in all.
6 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)
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 2.
- K052643: Epiceram, Ceragenix Corporation (2006) Summary page 2.
- K083024: Hylatopic Emollient Foam, Collegium Pharmaceutical Incorporated (2009) Summary page 2.

## Most influential descendants
- 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
- K123678: Hyalmix Cream (2013), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, Hylatopic Plus 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. Hylatopic Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Hylatopic Plus Emollient Foam is indicated for use in: * Atopic Dermatitis * Allergic Contact Dermatitis * Radiation Dermatitis

Source page: https://510kreport.com/device/K093051
Methodology: https://510kreport.com/methodology