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QLF1335T200Preliminary C0011001 May. 20131310 nm FP LASER TOCAN1. DESCRIPTION The QLF1335T200 is 1310 nm quantum dot laser diode device for use in extremely high temperature environment. The laser
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1 device 2 functions refers to a classification of medical devices that are designed to perform two distinct functions using a single device.
Manufacturers of medical devices that fit the 1 device 2 functions classification are required to file the necessary documentation with regulatory bodies.
To fill out the 1 device 2 functions documentation, manufacturers must provide detailed descriptions of each function, intended use, and any relevant clinical data.
The purpose of 1 device 2 functions is to ensure that medical devices meeting this classification are properly regulated for safety and efficacy.
Information that must be reported includes device specifications, intended use, function descriptions, safety data, and clinical evidence supporting effectiveness.
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