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The OpuDuo Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.

The Er: YAG laser component is indicated for caries removal, cavity preparation, and enamel etching.

The CO2 laser component is indicated for vaporization, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.

The Opus Spectrum c is a model of the Opus 20 Dental Laser System which is intended to aid during dental procedure performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er: Y AG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er:YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. . The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.

This document is a 510(k) summary for the Opus Spectrum dental laser system. It states that the Opus Spectrum is an improved model of the Opus 20 dental laser system and is substantially equivalent to the Opus 20. However, this document does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

The "Design Control Activities Summary" section mentions that "identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied are presented in Sections 6 and 8 of this submission." However, Sections 6 and 8 are not included in the provided text.

Therefore, I cannot provide the requested information.

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