(44 days)
The ERCHONIA® Verju™ Laser System with Massager is indicated for use as a non-invasive dermatological aesthetc treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist and thighs.
The Massager component is indicated for the temporary reduction in the appearance of cellulite.
Erchonia® Verju™ Laser System with Massager
This document is an FDA 510(k) clearance letter for the Erchonia® Verju™ Laser System with Massager. It addresses regulatory compliance and substantially equivalent determination but does not contain details about a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information, which typically pertains to studies involving AI/ML device performance. This document is a regulatory approval for a physical medical device (a laser system with a massager) and not an AI/ML diagnostic or therapeutic device.
§ 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.