# K143605: Nutraseb Facial Cream

- Pathway: 510(k) (Traditional)
- Applicant: Isdin Corp.
- Decided: Apr 14, 2016 after 482 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: 3 generations back to K961758 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050158: Sinclair Seborrhea Emulsion, Sinclair Pharmaceuticals, Ltd. (2006) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional, NUTRASEB Facial Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. NUTRASEB Facial Cream helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K143605
Methodology: https://510kreport.com/methodology