# K230382: 3 Series NeoLux

- Pathway: 510(k) (Special)
- Applicant: Daavlin Distributing Co.
- Decided: Mar 24, 2023 after 39 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K828654 (1983). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153749: 3 Series Phototherapy Unit, Daavlin Distributing Company (2016) Summary page 4.
- K210881: M Series Phototherapy Equipment, Daavlin Distributing Co. (2021) Summary page 4.

## Most influential descendants
- K261775: Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) (2026), 0 descendants of its own

## Indications for use
The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

Source page: https://510kreport.com/device/K230382
Methodology: https://510kreport.com/methodology