Vevazz LED Heat Lamp
FDA 510(k)Class II (US FDA 510(k))
by Vevazz, LLC
Identifiers
- 510(k) Number
- K162763 FDA 510(k)
- FDA Product Code
- ILY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vevazz LED Heat Lamp is a therapeutic infrared lamp classified as a Lamp, Infrared, Therapeutic Heating (product code ILY). It emits energy in the infrared spectrum to deliver localized, controlled heat for superficial tissue warming, aiding in pain relief, muscle relaxation, or therapeutic interventions in physical medicine settings. Designed as a prescription-use device, it operates via LED technology to provide consistent, adjustable thermal output without traditional heating elements.
This device is supplied as a reusable system comprising a base unit and modular LED paddles (up to 16 large and 4 small), each emitting infrared light at 650 nm with a power density of 50 mW/cm². It is intended for clinical use in controlled environments, such as physical therapy clinics or physician offices, and requires no sterilization due to its non-invasive, non-contact application. The device holds FDA 510(k) clearance (K162763) under the Physical Medicine (PM) advisory committee, classified as Class II with special controls. Storage instructions and MRI safety are not specified in the regulatory data.
Frequently asked questions
What is the Vevazz LED Heat Lamp used for in clinical settings?
The Vevazz LED Heat Lamp is designed for localized superficial tissue warming using infrared energy. It aids in pain relief, muscle relaxation, and therapeutic interventions in physical medicine, making it suitable for controlled environments like physical therapy clinics or physician offices. The device leverages LED technology to provide consistent, adjustable thermal output without the risks associated with traditional heating elements.
How is the Vevazz LED Heat Lamp supplied, and what components are included?
The device is supplied as a reusable system consisting of a base unit and modular LED paddles—up to 16 large and 4 small. Each paddle emits infrared light at a wavelength of 650 nm with a power density of 50 mW/cm². The modular design allows flexibility in treatment area coverage while maintaining a non-contact, non-invasive application.
Does the Vevazz LED Heat Lamp require sterilization, and why?
No sterilization is required for the Vevazz LED Heat Lamp because it is a non-invasive, non-contact device. Its design ensures no direct contact with the patient’s skin or internal tissues, eliminating the need for sterilization procedures. This simplifies clinical workflows while maintaining safety and hygiene standards.
Is the Vevazz LED Heat Lamp single-use or reusable, and how does that affect its use?
The Vevazz LED Heat Lamp is designed as a reusable device, which means it can be used repeatedly across multiple patients in a clinical setting. This reduces waste and operational costs while maintaining consistent performance. The modular LED paddles are also reusable, provided they are handled and stored properly to preserve their functionality and safety.
What regulatory clearance does the Vevazz LED Heat Lamp hold, and how does that apply to its use?
The Vevazz LED Heat Lamp holds FDA 510(k) clearance (K162763) under the Physical Medicine (PM) advisory committee, classified as a Class II device with special controls. This clearance confirms that the device meets regulatory standards for safety and effectiveness in its intended use—localized superficial tissue warming for therapeutic purposes in clinical settings. The classification ensures it adheres to specific manufacturing, labeling, and performance requirements.
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: Vevazz LLC - 592118 - 12/26/2019 | FDA, K162763 FDA 510 (k) - Vevazz LED Heat Lamp | Vevazz, LLC, Vevazz LED Heat Lamp (K162763) — FDA 510 (k) | Innolitics, Vevazz LED Heat Lamp - healthcareequipment.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162763 | Class II | Active |
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Manufacturer
- Manufacturer
- Vevazz, LLC
Sources (1)
- FDA 510(k) K162763 24 fields · synced Oct 1, 2026