Non-Contact Infrared Thermometer HL710H
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211744 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Non-Contact Infrared Thermometer HL710H is a non-invasive medical device classified as a non-contact infrared thermometer. It measures human body temperature by detecting infrared radiation emitted from the forehead, providing rapid and contactless temperature assessment without physical contact. Designed for clinical use, it is intended to support screening and monitoring of body temperature in healthcare settings. The device operates on the principle of infrared thermometry, ensuring accuracy and efficiency in temperature readings.
The HL710H is supplied as a single-use or reusable device (as per manufacturer specifications) and is intended for use in general hospital environments. It is not explicitly stated to be sterile upon packaging, but standard infection control practices should be followed during use. The device is FDA-cleared under the 510(k) pathway (K211744) and falls under product code FLL. Storage conditions and regulatory compliance should align with manufacturer guidelines and local healthcare protocols.
Frequently asked questions
What is the HL710H Non-Contact Infrared Thermometer used for?
The HL710H is designed for non-invasive, contactless temperature assessment by detecting infrared radiation from the forehead. It supports rapid screening and monitoring of body temperature in clinical settings, helping to identify fever or temperature fluctuations without physical contact. This is particularly useful in environments where minimizing exposure to pathogens is critical, such as hospitals or public health screenings.
Is the HL710H supplied as single-use or reusable?
The HL710H can be used either as a single-use or reusable device, depending on the specific application and facility protocols. While the manufacturer does not specify sterility upon packaging, standard infection control practices must be followed to ensure safe use. Reusable units should undergo appropriate cleaning and disinfection between patients, while single-use units should be discarded after one use to maintain hygiene standards.
What storage conditions should be followed for the HL710H?
Storage conditions for the HL710H should align with the manufacturer’s guidelines to preserve accuracy and functionality. While specific details are not provided in the data, typical recommendations for infrared thermometers include storing the device in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of electromagnetic interference. Ensure the device is protected from physical damage and moisture to maintain its performance.
How does the HL710H ensure accurate temperature readings?
The HL710H operates using infrared thermometry, which measures the thermal radiation emitted by the forehead. This method provides rapid and precise readings without physical contact, reducing the risk of cross-contamination. The device’s design ensures consistent accuracy by focusing on a specific area of the forehead, where temperature closely correlates with core body temperature. Regular calibration and adherence to manufacturer instructions further support reliable performance.
What regulatory pathway does the HL710H follow?
The HL710H is FDA-cleared under the 510(k) pathway, specifically through clearance number K211744. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, meeting the regulatory requirements for safety and effectiveness in its intended use. The product code FLL categorizes it under general hospital equipment, and compliance with local healthcare protocols is essential for proper integration into clinical workflows.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Non-Contact Infrared Thermometer, model HL710H, Non-Contact Infrared Thermometer model HL710H, Non-Contact Infrared Thermometer, model HL710H by Health & Life Co ..., Health Life HL710H - device.report, Non-Contact Infrared Thermometer, Model HL710H… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211744 | Class II | Active |
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Manufacturer
- Manufacturer
- Health & Life Co., Ltd.
Sources (1)
- FDA 510(k) K211744 24 fields · synced Oct 5, 2026