# K162217: LOYON

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences
- Decided: Mar 23, 2017 after 227 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: 8 generations back to K830708 (1983). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152945: Alevicyn SG Antipruritic Gel, Oculus Innovative Sciences (2015) Summary page 4.
- K090337: Tropazone Lotion, Midlothian Laboratories (2009) Summary page 4.

## Indications for use
Rx Indication: Under the supervision of a health care professional, LOYON is indicated to manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis.

Source page: https://510kreport.com/device/K162217
Methodology: https://510kreport.com/methodology