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For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery.

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This document is a 510(k) clearance letter for the Erchonia EML Laser, indicating that the device has been found substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, and performance metrics as they would typically be found in a clinical study report or a more comprehensive premarket submission summary.

The letter only provides the following:

1. Device Name: Erchonia EML Laser
2. 510(k) Number: K072206
3. Indication for Use: "For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery."

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study results, sample sizes, ground truth establishment, or expert qualifications based solely on the provided text. These details are typically part of the supporting documentation referenced in such clearance letters but are not explicitly presented within the letter itself.

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The Erchonia EML is indicated as an adjunct to liposuction procedures of the hips and stomach for reduction of pain associated with the recovery process.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The text is a 510(k) clearance letter from the FDA for a medical device (Erchonia EML Laser) and primarily discusses regulatory aspects such as substantial equivalence, classification, and general controls. It does not include details about device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications.

Ask a specific question about this device