# K100378: 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4

- Pathway: 510(k) (Traditional)
- Applicant: Daavlin Distributing Co.
- Decided: Apr 28, 2010 after 71 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: 2 generations back to K828654 (1983). 7 ancestors in all.
6 later devices descend from it; 3 cite 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)
- K073587: Dermapal with Digital Timer, Daavlin Distributing Co. (2008) Summary page 2.
- K050695: Flex Controlled Phototherapy Equipment, Daavlin Distributing Co. (2005) Summary page 2.
- K070934: Panosol II Tru-Blu, Model Ubl-417, National Biological Corp. (2007) Summary page 2.
- K031805: Blu-U, Model 4170, Dusa Pharmaceuticals, Inc. (2003) Summary page 2.

## Most influential descendants
- K182215: ClearLink Controlled Phototherapy Equipment (2018), 4 descendants of its own
- K210881: M Series Phototherapy Equipment (2021), 2 descendants of its own
- 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
- K212510: 7 Series Phototherapy Device (2021), 0 descendants of its own

## Recalls of this device
- Apr 26, 2022 · Class II · Z-1073-2022: 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 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L-36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris

Source page: https://510kreport.com/device/K100378
Methodology: https://510kreport.com/methodology