# K050695: Flex Controlled Phototherapy Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Daavlin Distributing Co.
- Decided: Apr 19, 2005 after 32 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: 1 generation back to K828654 (1983). 2 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K828654: Uvb Cabinet or Goekerman Cabinet, Model Spectra 305, Daavlin Co. (1983) Summary page 1.
- K854498: Spectra 724, Daavlin Co. (1985) Summary page 1.

## Cited in the summary but kept off the family tree
- K820690: Daavlin Distributing Company Spectra Mini Series, Ultraviolet Phototherapy Device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K100378: 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 (2010), 6 descendants of its own
- 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
- K111049: Mobile Versa Light (2012), 1 descendant of its own

## Indications for use
The Flex controlled phototherapy equipment is a medical ultraviolet device, 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/K050695
Methodology: https://510kreport.com/methodology