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WS-501 Heat Lamp

by Lhasa Medical, Inc.

510(k) K013197

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK013197 Date29 Aug 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 WS-501 Heat Lamp is a heat therapy device designed for topical application to provide localized warmth. It employs a rare earth ceramic plate to emit infrared radiation across a spectrum of 0.5 to 13,500 microns, delivering controlled thermal energy for therapeutic purposes.

This device operates on 110 volts with a power output of 20 watts, featuring adjustable heat settings via a high/low switch. Supplied as a handheld unit with an optional tabletop stand, it is intended for single-use applications in clinical or home settings. The ceramic plate has a lifespan of 5,000 to 10,000 hours of continuous use, and the device carries FDA 510(k) clearance under classification ILY (Physical Medicine)

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Questions

AI-generated answers, 19 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 types of conditions or areas of the body is the WS-501 Heat Lamp intended to treat or provide warmth to?

    The WS-501 Heat Lamp is designed for topical application to deliver localized warmth through infrared radiation (0.5–13,500 microns). It is intended for use in physical medicine therapy, such as muscle relaxation, joint stiffness relief, or pain management in specific areas like shoulders, back, or extremities. The adjustable heat settings (high/low) allow for controlled thermal energy delivery, making it versatile for clinical or home use where targeted warmth is needed.

  • How long can I expect the ceramic heating element in the WS-501 to last before needing replacement?

    The ceramic plate in the WS-501 is rated for a lifespan of 5,000 to 10,000 hours of continuous use. This means, depending on usage frequency, it could last several years for typical clinical or home applications. The device is designed for single-use applications, though the ceramic plate itself is durable enough to be reused within its operational lifespan.

  • Is the WS-501 Heat Lamp meant for reusable clinical settings, or is it designed for single-patient use?

    The WS-501 is supplied as a handheld unit and is intended for single-use applications in both clinical and home settings. While the ceramic plate itself has a long lifespan (5,000–10,000 hours), the device is not explicitly marketed for reuse across multiple patients. Clinicians should follow facility protocols for disinfection or replacement if the device is used in shared environments.

  • What power source and voltage requirements does the WS-501 Heat Lamp use, and does it come with any accessories?

    The WS-501 operates on 110 volts and has a power output of 20 watts, making it compatible with standard household or clinical electrical outlets. It is supplied as a handheld unit and includes an optional tabletop stand for stable positioning during use. No additional power adapters or accessories are mentioned beyond these two components.

  • How does the WS-501’s infrared radiation spectrum compare to traditional heat therapy devices, and what does that mean for its effectiveness?

    The WS-501 emits infrared radiation across a broad spectrum (0.5 to 13,500 microns), which is characteristic of far-infrared therapy. This spectrum is often associated with deeper tissue penetration compared to conventional conductive heat sources (like heating pads), potentially enhancing therapeutic effects for conditions like muscle soreness or joint stiffness. The adjustable high/low settings allow clinicians or users to tailor the warmth level to the patient’s needs.