# K110727: Hylatopicplus Cream

- Pathway: 510(k) (Special)
- Applicant: Precision Dermatology Incorporated
- Decided: Apr 1, 2011 after 16 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: 6 generations back to K961758 (1996). 8 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093051: Hylatopic Plus Emollient Foam, Collegium Pharmaceutical Incorporated (2009) Summary page 1.

## Most influential descendants
- 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
- K121559: Hylatopicplus Lotion (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K110727
Methodology: https://510kreport.com/methodology