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Infrared Ear Thermometer

by Sejoy Electronics & Instruments Co., Ltd. 510(k)

Active United States

510(k) K153146

Overview

The Infrared Ear Thermometer is a medical device designed to measure body temperature using infrared technology. It provides readings in seconds and features a pre-warmed tip for improved accuracy and comfort. The device includes a unique guidance system to ensure precise results and can be used for adults, children, and babies.

This thermometer is supplied with probe covers and has a memory function storing up to 10 readings. It operates with dual temperature scales (C°/F°) and beeps when ready. The device is authorized under FDA 510K clearance with product code FLL and is manufactured by Sejoy Electronics & Instruments Co., Ltd.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153146 Date31 Mar 2016ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

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

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Questions

  • What is the Infrared Ear Thermometer used for?

    The Infrared Ear Thermometer is designed to measure body temperature using infrared technology. It provides readings in seconds and can be used for adults, children, and babies, featuring a pre-warmed tip for improved accuracy and comfort.

  • How is the Infrared Ear Thermometer supplied?

    The thermometer is supplied with probe covers and includes a memory function that can store up to 10 readings. It operates with dual temperature scales (C°/F°) and beeps when ready to indicate the reading is complete.

  • What is the regulatory status of this thermometer?

    The Infrared Ear Thermometer is authorized under FDA 510K clearance with product code FLL. It was manufactured by Sejoy Electronics & Instruments Co., Ltd. and received clearance on March 31, 2016.

  • Does the Infrared Ear Thermometer require special storage conditions?

    The device should be stored in a clean, dry place at room temperature. Avoid exposing it to extreme temperatures, humidity, or direct sunlight to maintain proper functionality and accuracy of temperature readings.