# K182215: ClearLink Controlled Phototherapy Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Daavlin Distributing Company
- Decided: Oct 29, 2018 after 75 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.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050695: Flex Controlled Phototherapy Equipment, Daavlin Distributing Co. (2005) Summary page 4.
- K100378: 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4, Daavlin Distributing Co. (2010) Summary page 4.

## Most influential descendants
- 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
- Mar 5, 2026 · Class II · Z-2744-2026: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

## Indications for use
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.

Source page: https://510kreport.com/device/K182215
Methodology: https://510kreport.com/methodology