# K253911: Derma-2

- Pathway: 510(k) (Traditional)
- Applicant: Neko Health AB
- Decided: May 20, 2026 after 163 days
- Product code: LHQ (System, Telethermographic (Adjunctive Use))
- Device class: 1
- Regulation: 21 CFR 884.2980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K063047 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200999: Thermidas IR System (ThIR-A615), Thermidas Americas, Inc. (2021) Summary page 6.

## Indications for use
The Derma-2 device is intended for adjunctive use in addition to other clinical methods and procedures for visually and thermally significant indications of an individual’s skin. The Derma-2 device is intended for displaying, reviewing, and reporting of images of the skin as well as temperature patterns and changes. The significance of these images and thermal patterns is determined by professional investigation. The Derma-2 device is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device. The Derma-2 device is intended for use by trained personnel. The Derma-2 system provides relative surface temperature information only. The device does not identify anatomical structures. Interpretation of thermal patterns remains solely the responsibility of the qualified healthcare professional.

Source page: https://510kreport.com/device/K253911
Methodology: https://510kreport.com/methodology