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Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

by Nexmed Technology Co., Ltd.

510(k) K160816

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160816↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK160816 Date21 Sep 2016ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Infrared Thermometer (Models: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) is a non-contact infrared thermometer designed for measuring body temperature in infants and adults without physical contact. It operates by detecting radiated infrared energy from the human forehead, converting it into an electronic signal, and processing it to display a temperature reading on an LCD screen.

These models are intended for use in both household and clinical environments by consumers or clinicians as a reference tool. Supplied as single-use or reusable devices (as applicable to each model), they comply with FDA 510(k) clearance and MDD authorisations. Models may feature variations in form factors, including rechargeable batteries or Bluetooth connectivity, but no specific sterility or MRI safety information is provided.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical or household environments is this infrared thermometer suitable for measuring temperature in adults and infants?

    This infrared thermometer is designed for use in both clinical and household settings. It measures body temperature non-invasively by detecting infrared energy from the forehead, making it practical for quick reference in hospitals, clinics, or at home. The device is intended for use by clinicians or consumers as a supplementary tool, not as a standalone diagnostic instrument.

  • Are these models single-use or reusable, and how does that affect their use in clinical settings?

    The models vary in usage: some are single-use, while others are reusable. For clinical settings, the reusable models offer cost efficiency and repeated use, but they require proper cleaning and maintenance between patients. Single-use models eliminate cross-contamination risks but must be disposed of after one use. The manufacturer does not specify sterilization methods, so clinical users should follow facility protocols for reusable devices.

  • What variations in form factors or connectivity options are available across these models, and how might they impact usability?

    The models include variations such as rechargeable batteries (for extended use) and Bluetooth connectivity (for wireless data transfer). For example, the PRO LX-261E and LX-361T likely offer advanced features like Bluetooth, which can streamline data logging in clinical workflows, while the LX-26E and LX-260TE may prioritize simplicity and portability. These differences cater to different user needs, such as ease of use in home settings versus integration into digital health records in clinical environments.

  • How does the FDA clearance and MDD authorization impact the use of these devices in regulated healthcare facilities?

    The FDA 510(k) clearance and MDD authorization indicate that these devices meet regulatory standards for safety and performance in their intended markets. In regulated healthcare facilities, this clearance allows clinicians to use these thermometers as a reference tool for temperature measurement, though they should not replace traditional clinical-grade devices for diagnostic purposes. The authorization also ensures compliance with European medical device directives if used in MDD-regulated regions.