# K112929: Thermoflash (TM) Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Visiomed Group SA
- Decided: Oct 18, 2011 after 15 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- 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 K090361 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090361: Remote Infrared Thermometer, Model RC002, Rycom Electron Technology Limited (2009) Summary page 2.

## Indications for use
ThermoFlash™ is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contacting to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Source page: https://510kreport.com/device/K112929
Methodology: https://510kreport.com/methodology