(90 days)
The Erchonia® Zerona 6 Headed Scamer (EZ6) device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, thighs and upper abdomen when applied to individuals with body mass index between 25 kg/m2 and 40 kg/m2.
Not Found
The provided document is a 510(k) clearance letter for the Erchonia® Zerona 6 Headed Scanner (EZ6) device. It is a regulatory document and does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you are requesting.
Therefore, I cannot provide the requested information based on the content of 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.