ELITE ELECTROMED L.I.T.E. 4/1

• K Number: K053507
• Device Name: ELITE ELECTROMED L.I.T.E. 4/1
• Manufacturer: ELITE ELECTROMEDICAL
• Date Cleared: 2006-03-15 ( 89 days)
• Product Code: NHN
• Regulation Number: 890.5500
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

THE L.I.T.E. 4/1 IS INDICATED FOR THE TREATMENT OF NECK AND SHOULDER PAIN OF MUSCULOSKELET OF ORIGIN.

Device Description

Not Found

AI/ML Overview

This document is correspondence from the FDA regarding a 510(k) premarket notification for a medical device. It does NOT contain information about acceptance criteria, study details, or performance metrics for the device. Therefore, I cannot extract the requested information.

The document indicates that the device, "Elite Electromedical L.I.T.E. 4/1 Diode Laser," is substantially equivalent to legally marketed predicate devices for the treatment of neck and shoulder pain of musculoskeletal origin. However, the letter does not provide any performance data or study details to support this determination.

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.