(470 days)
The eon™ FR (1064nm laser) is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index (BMI) of 30 or less.
Not Found
This FDA document is a 510(k) clearance letter for the Eon™ FR device, which is a low-level laser system for aesthetic use. It indicates that the device is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells in individuals with a Body Mass Index (BMI) of 30 or less. However, the document does not contain any information regarding specific acceptance criteria, study details, or performance metrics for the device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the provided text. The document confirms the device's regulatory clearance and its intended use, but not the technical data supporting that clearance.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.