# K210881: M Series Phototherapy Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Daavlin Distributing Co.
- Decided: Jun 22, 2021 after 89 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.
2 later devices descend from it; 1 cites it directly.
0 of 12 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 5.
- K100378: 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4, Daavlin Distributing Co. (2010) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- Mar 5, 2026 · Class II · Z-2742-2026: 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 M 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 physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.

Source page: https://510kreport.com/device/K210881
Methodology: https://510kreport.com/methodology