VisioFocus Mini, VisioFocus Smart

FDA 510(k) K160680 · Tecnimed S.R.L.

Substantially Equivalent

510(k) numberK160680

Submission

Device name
VisioFocus Mini, VisioFocus Smart
Applicant
Tecnimed S.R.L.
Vedano Olona, IT
Received
March 10, 2016
Decision date
April 19, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FLL – Continuous Measurement Thermometer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2910
Specialty
General Hospital

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Other 510(k)s with product code FLL

510(k)DeviceApplicantDecision
K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional Unimed Medical Supplies, Inc.06/05/2026SE
K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional Shenzhen Med-Link Electronics Tech Co., Ltd.01/08/2026SE
K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional Shenzhen AOJ Medical Technology Co., Ltd.06/23/2025SE
K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…FLL · Traditional Shenzhen Medke Technology Co., Ltd.06/20/2025SE
K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.05/22/2025SE
K243082Infrared ThermometerFLL · Traditional Guangzhou Daxin Health Technology Co., Ltd.04/25/2025SE
K250401AION TempShield™FLL · Traditional Aion Biosystems, Inc.03/14/2025SE
K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…FLL · Traditional Shenzhen Finicare Co., Ltd.02/14/2025SE
K240333Wearable Digital Thermometer (T31)FLL · Traditional Guangdong Genial Technology Co., Ltd.10/30/2024SE
K240223FMT Disposable and Autoclavable Temperature ProbesFLL · Traditional Metko Medikal VE Tibbi Cihazlar Dis Ticaret…10/25/2024SE

More from Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi

510(k)DeviceDecision
K122412VisiofocusFLL · Special 03/13/2013SE
K072108Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesFLL · Special 08/31/2007SE
K033790Thermofocus 0800, 0900, 01500 and 0700 SeriesFLL · Traditional 06/03/2004SE

Questions and answers

When was VisioFocus Mini, VisioFocus Smart cleared by the FDA?

VisioFocus Mini, VisioFocus Smart (K160680) received a 510(k) decision of Substantially Equivalent on April 19, 2017, 405 days after the submission was received.

What is the product code of K160680?

The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.