(363 days)
The InvisaRED™ Technology ELITE is indicated for use as a non-invasive dermatological aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation, affecting adipocyte cells within the adipose layer for the release of lipids from these cells.
Device console:
- Electrical Power: 110v
- Cooling: Air Cooled
- Operation: LCD touch screen
- Allows Control of Individual Patient Session Protocol (Time, Energy, Pulse, Delay)
- Integrated Device Power-On Self Test
- Emergency Safety cut off switch
- Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12
- Paddle Cooling: Air cooled
- . Dual Coherent Frequencies: Thirteen (13) 680nm and thirteen (13) 980nm laser diodes on each paddle
- Concurrent Laser Diode Mode of Operation: pulsed or continuous output
- . Power output: Variable up to 200mw per diode for both 680nm and 980mm wavelengths
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criterion for the InvisaRED™ Technology ELITE, as inferred from the clinical study, is the demonstration of superiority over a sham device in temporarily reducing the circumference of the waist, hips, and thighs.
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance (Invisa-RED Elite) |
|---|---|
| Superiority to sham/placebo device in reducing measured body circumference (waist, hips, thighs) | An estimated mean difference of 6.880 inches greater loss when comparing the totals of the measured areas of subjects treated with the Invisa-RED Elite vs. the placebo device. |
| 95% confidence interval: 3.715 inches to 10.046 inches | |
| Two-tailed P value: |
§ 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.