# K160680: VisioFocus Mini, VisioFocus Smart

- Pathway: 510(k) (Traditional)
- Applicant: Tecnimed S.R.L.
- Decided: Apr 19, 2017 after 405 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
VisioFocus SMART and VisioFocus Mini are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages. This thermometer is for a measurement site of forehead.

Source page: https://510kreport.com/device/K160680
Methodology: https://510kreport.com/methodology