(206 days)
The MicroLight ML830 d contains infrared lamps that 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 relaxtion of pain, artifitis and inuscle spassily increase local blood circulation where applied.
The ML830®d is an innovative, safe, easy to use, hand-held, non-invasive device The ML830 u is an innovative, sare, easy es approximately % pound and has a designed for in-nonic use. "The device worgine upper of these (34 square centimeters).
The ML830®d contains 12 light emitting diodes and 12 infrared diodes with The NILGSV a commits TF ingile change
wavelengths of 660 nanometers, and 880 nanometers, respectively, with total or waverongais of approximately 500 milliwatts.
The provided text is a 510(k) Premarket Notification Summary for the ML830®d infrared lamp. This document outlines the device's technical characteristics and intended use but does not contain any information about a study with acceptance criteria or reported device performance.
The core of this document is to demonstrate that the ML830®d is substantially equivalent to a predicate device, the Dio LFT 3000 (cleared under K022888). Substantial equivalence means that a new device is as safe and effective as a legally marketed predicate device. This typically relies on comparing design, materials, chemical composition, energy source, and intended use, rather than conducting new clinical trials for safety and effectiveness.
Therefore, I cannot provide the requested information because the document does not describe a study that proves the device meets acceptance criteria. The clearance is based on its identity to a previously cleared device.
§ 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.