MB System BioEnergy Light Therapy
by Amest Corp.
510(k) K030275
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030275 | Date29 Nov 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 1 Oct 2026
The MB System BioEnergy Light Therapy is a Lamp, Infrared, Therapeutic Heating device, classified under the FDA’s Physical Medicine category. It employs an array of infrared light-emitting diodes (LEDs) to deliver controlled thermal energy to targeted tissue, promoting localized heating for therapeutic purposes. Designed as a Class II medical device, it operates by emitting infrared radiation to elevate tissue temperature without direct contact. The system is intended for temporary relief of musculoskeletal discomfort, including muscle pain, spasms, and stiffness.
This device is supplied as a reusable therapeutic lamp with front-panel controls for adjusting oscillation frequency, intensity, and treatment duration. It requires no sterilization and is intended for use in clinical or home settings, though its application is limited to external, non-invasive thermal therapy. The MB System BioEnergy Light Therapy holds FDA 510(k) clearance (K030275) under the traditional review pathway, with no third-party review. Storage and operational use follow standard electrical safety and thermal therapy guidelines as outlined in the manufacturer’s instructions.
Questions
AI-generated answers, 1 Oct 2026
What is the MB System BioEnergy Light Therapy Lamp used for?
This device is designed for temporary relief of musculoskeletal discomfort, including muscle pain, spasms, and stiffness. It achieves this through controlled thermal energy delivered via infrared LEDs, which elevate tissue temperature without direct contact. The therapy is non-invasive and intended for external use only.
Is the MB System BioEnergy Light Therapy Lamp reusable or single-use?
The MB System BioEnergy Light Therapy Lamp is a reusable therapeutic lamp. It is not intended for single-use and is designed for repeated applications in clinical or home settings. No sterilization is required, as it is not a sterile device.
How do you adjust treatment settings on the MB System BioEnergy Light Therapy Lamp?
The device features front-panel controls that allow users to adjust three key parameters: oscillation frequency, intensity, and treatment duration. These settings enable customization of the thermal therapy to target specific areas and discomfort levels.
Can the MB System BioEnergy Light Therapy Lamp be used at home?
Yes, the MB System BioEnergy Light Therapy Lamp is intended for use in both clinical and home settings. It is designed for external, non-invasive thermal therapy, making it accessible for self-administered relief of musculoskeletal discomfort when used according to the manufacturer’s instructions.
How should the MB System BioEnergy Light Therapy Lamp be stored?
Storage and operational use of the MB System BioEnergy Light Therapy Lamp follow standard electrical safety and thermal therapy guidelines. The manufacturer’s instructions provide specific details on proper storage conditions, including protection from moisture, extreme temperatures, and physical damage to ensure safe and effective performance.