(108 days)
The Erchonia® MLS, Zerona™ is indicated for non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called Erchonia® MLS, Zerona™. It primarily communicates the FDA's decision regarding substantial equivalence and regulatory compliance. It does not contain information about acceptance criteria for a study, nor does it describe a study's methodology or results in detail. Therefore, I cannot extract the information required to answer your request.
The letter states the "Indications for Use" for the device, which is "non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms." However, it does not provide acceptance criteria or a study proving that the device meets such criteria.
§ 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.