(302 days)
The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.
EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.
Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned by a robotic arm. The treatment head is never in contact with the skin.
During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (42°C to 50°C). The cooling system will maintain the skin at comfortable temperature (
Here's a breakdown of the acceptance criteria and the study details for the EON device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Objectives) | Reported Device Performance and Study Success |
|---|---|
| Primary Objective: Confirm safety of the 1064-nm laser device for non-invasive subcutaneous fat reduction in the flank area. | Low incidence of adverse effects (only 1 subject developed palpable thickening, resolved by Week 12). Mean pain score during procedure was 1.95 (0-10 scale), decreasing to 0.9 at 30 minutes post-procedure. |
| Primary Efficacy Endpoint: Blinded evaluation of pre- and post-treatment photos. Study success if at least two of three independent readers correctly identify at least 9 of 11 photo sets as pre-treatment. | 27 (81.8%) of 33 image sets were correctly scored overall. Two of the three readers correctly identified pre- and post-treatment photos in at least 9 of 11 subjects, thus achieving study success. |
| Secondary Efficacy Endpoint: Mean fat reduction by ultrasound. | At Week 12 after one treatment, the mean reduction in subcutaneous adipose thickness was 6.1 mm per flank and 12.1 mm per patient (-15%; p |
§ 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.