(97 days)
The Cynosure SculpSure™ 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. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a Body Mass Index (BMI) of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
The document describes a clinical study conducted to evaluate the safety and efficacy of the Cynosure SculpSure laser system with a new petite mask for non-invasive fat reduction and improvement of lax tissue appearance in the submental area.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state the acceptance criteria as a separate table. Instead, it describes the endpoints that were evaluated and the results. I will infer the acceptance criteria from the "met all three endpoints to prove safety and efficacy" statements.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| For Non-Invasive Fat Reduction: | |
| 1. Significant change in adipose tissue thickness from baseline. | Reduction in adipose tissue measured by ultrasound imaging at 12-week post follow-up visit showed a p-value of |
§ 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.