(405 days)
The SLIMUS is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.
The SLIMUS device incorporates a laser system that emits a 1060 nm wavelength using a diode laser. Laser radiation is emitted from the laser main unit to the device's handpieces through the handpiece fibers. The device is used to noninvasively reduce the size of the waist of overweight patients with a Body Mass Index (BMI) of less than 30 (kg/m²). A vibrator function is installed inside of each hand-piece and operable only in non-laser output mode. The device's handpieces are fixed to a belt which then combined provide mechanical vibration to the patient in order provide relief from minor muscle aches and pains.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) premarket notification summary for the SLIMUS device, primarily demonstrating its substantial equivalence to a predicate device (SculpSure™).
Specifically, the document states in section 8: "No Clinical performance testing was performed." This means there isn't a study proving the device's performance against specific acceptance criteria in a clinical setting provided in this document.
Therefore, I cannot provide the requested information in the table or answer the questions related to clinical study design, as no such study is presented in this document. The provided text focuses on non-clinical testing and technological comparisons to establish substantial equivalence.
§ 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.