IR Pro 250

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

510(k) Number

K061080 ↗

FDA Product Code

ILY

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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See all devices from Lhasa Oms, Inc. →

• What clinical applications is the IR Pro 250 infrared heat therapy lamp primarily used for?

  The IR Pro 250 is designed for physical medicine applications, specifically to provide localized radiant heat therapy. It is used for pain relief, muscle relaxation, and promoting tissue healing by delivering controlled warmth to targeted areas. This makes it suitable for both clinical and home settings where non-invasive thermal therapy is needed.

• Is the IR Pro 250 lamp reusable or single-use, and what does that mean for maintenance?

  The IR Pro 250 is supplied as a reusable unit, meaning it is intended for repeated use after cleaning and maintenance. Since it is non-sterile, it should not be used in sterile procedures, but it can be cleaned and reused for non-invasive physical medicine applications in clinical or home settings. Always follow manufacturer guidelines for proper care to ensure safe and effective operation.

• What power requirements does the IR Pro 250 have, and does it pose any safety concerns with MRI equipment?

  The IR Pro 250 operates on standard household power of 110V at 60Hz, making it compatible with typical clinical or home electrical outlets. Importantly, the device is labeled as having no regulatory restrictions for MRI safety, meaning it is considered safe to use in areas where MRI scans are performed without interfering with the equipment or posing risks to patients.

• How do I determine the correct size or model of IR Pro 250 for my needs?

  The IR Pro 250 is a single model device, so there are no varying sizes or configurations to choose from. It is designed as a unified infrared heat therapy lamp for localized warming in physical medicine applications. If you require adjustments in heat intensity or coverage area, the device’s design and placement should be optimized based on clinical guidelines for therapeutic heat therapy.