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The Erchonia® Zerona™ 2.0 Laser is indicated for use as a noninvasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

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The provided document is a 510(k) summary for the Erchonia® Zerona™ 2.0 Laser. It primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical study reports or comprehensive device documentation.

Therefore, I cannot provide the requested information from the given text. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Information on a multi-reader, multi-case study or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• Method for establishing ground truth for the training set.

The document only states the "Indications for Use" for the device, which is "as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs." To find the specifics of how this claim was substantiated, one would need to refer to the actual studies conducted by Erchonia Corporation and submitted to the FDA, which are not part of this 510(k) summary letter.

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