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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.

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