(77 days)
The Erchonia Zerona is indicated for use 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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Erchonia Zerona device. It states that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods.
The letter is a regulatory approval, not a scientific study report. It confirms the device's clearance for marketing based on its substantial equivalence to another device and its stated Indications for Use.
Therefore, I cannot provide the requested information from the given input.
§ 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.