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The Cutera CMMCD infrared and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The Cutera CMMCD massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Cutera CMMCD treatment consists a massage device and an infrared light(optional)/RF device. Topical heating for the purpose of elevating tissue temperature is derived from conducted RF energy/optional infrared light. Mechanical manipulation is derived from a vacuum assisted massage with rollers. The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied.

The provided text is a 510(k) summary for the Cutera CMMCD device. It explicitly states that "No clinical data was needed to prove substantial equivalence" and that the device was found substantially equivalent to predicate devices based on similar indications for use, design features, and functional features.

Therefore, the information required to populate the acceptance criteria and study details is not available in the provided document. The device did not undergo a study to prove it meets acceptance criteria, as its market clearance was based on substantial equivalence to existing devices without the need for new clinical data.

Specifically, the document states:

• "No clinical data was needed to prove substantial equivalence." (Section VI. Rationale for Substantial Equivalence)
• "Technologically, the Cutera CMMCD is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera CMMCD are comparable to the predicate devices." (Section VII. Safety and Effectiveness Information)
• "We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device." (Section VII. Safety and Effectiveness Information)

Since no clinical study was conducted to demonstrate device performance against acceptance criteria, the specific details requested in the prompt cannot be extracted from this 510(k) summary.

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