# K123678: Hyalmix Cream

- Pathway: 510(k) (Traditional)
- Applicant: Igi Laboratories, Inc.
- Decided: Dec 16, 2013 after 381 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, Hylamnix 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. Hylamix Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Hylamix Cream in indicated for use in: *Atopic Dermatitis *Allergic Contact Dermatitis *Radiation Dermatitis

Source page: https://510kreport.com/device/K123678
Methodology: https://510kreport.com/methodology