# K121559: Hylatopicplus Lotion

- Pathway: 510(k) (Special)
- Applicant: Precision Dermatology Incorporated
- Decided: Nov 30, 2012 after 185 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: 7 generations back to K961758 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110727: Hylatopicplus Cream, Precision Dermatology Incorporated (2011)

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

Source page: https://510kreport.com/device/K121559
Methodology: https://510kreport.com/methodology