# K111172: 4 Series Phototherapy Unit Model 4 Series

- Pathway: 510(k) (Traditional)
- Applicant: Daavlin Distributing Co.
- Decided: Aug 29, 2011 after 125 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K828654 (1983). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100378: 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4, Daavlin Distributing Co. (2010) Summary page 1.

## Recalls of this device
- Apr 26, 2022 · Class II · Z-1074-2022: Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

## Indications for use
The 4- Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.

Source page: https://510kreport.com/device/K111172
Methodology: https://510kreport.com/methodology