# K153749: 3 Series Phototherapy Unit

- Pathway: 510(k) (Special)
- Applicant: Daavlin Distributing Company
- Decided: Jun 30, 2016 after 184 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: 2 generations back to K828654 (1983). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063621: 3 Series Phototherapy Cabinet, Daavlin Co. (2007) Summary page 4.

## Most influential descendants
- K230382: 3 Series NeoLux (2023), 1 descendant of its own
- K261775: Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) (2026), 0 descendants of its own

## Indications for use
The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).

Source page: https://510kreport.com/device/K153749
Methodology: https://510kreport.com/methodology