FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Light-Force-Therapy line of infrared lamps are indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. The document is primarily an FDA 510(k) clearance letter for an infrared lamp, confirming its substantial equivalence to a predicate device and outlining regulatory information. It does not include a study report or data on the device's performance against specific acceptance criteria.

Ask a Question

Ask a specific question about this device

K Number

K001179

Device Name

SUPER NOVA, ACUBEAM

Manufacturer

LIGHT FORCE THERAPY, INC.

Date Cleared

2000-10-27

(199 days)

Product Code