# K212510: 7 Series Phototherapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Daavlin Distributing Co.
- Decided: Nov 4, 2021 after 86 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: 4 generations back to K828654 (1983). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182215: ClearLink Controlled Phototherapy Equipment, Daavlin Distributing Company (2018) Summary page 4.

## Recalls of this device
- Mar 5, 2026 · Class II · Z-2743-2026: 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 7 Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

Source page: https://510kreport.com/device/K212510
Methodology: https://510kreport.com/methodology