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ALT Laser, Model VTR75 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

The system will produce a 980nm infrared and a 660 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 660 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 660 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.

This 510(k) submission for the ALT Laser, Model VTR75, does not contain acceptance criteria or a study proving the device meets said criteria.

Instead, this document is a 510(k) summary (K031612) and the FDA's clearance letter. The summary describes the device, its intended use, contraindications, and warnings. The FDA letter confirms that the device has been found substantially equivalent to a predicate device (BioScan, Inc., BioPack, K993685) and can be marketed.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance acceptance criteria or a study demonstrating achievement of those criteria.

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