(84 days)
The Visage Cosmetic Surgery System is intended for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer's Lactate as an irrigant.
The Visage Cosmetic Surgery System is shown in Figure 1 (Figures Section), and includes three components. The components are the Handpiece and Cable unit, Handpiece Tip, and the Controller. The Handpiece Tip attaches to the distal end of the Handpiece and Cable unit. The proximal end of the Handpiece and Cable unit connects to the Controller.
The Handpiece Tip is provided in a variety of electrode configurations. The distal tip of the Handpiece is configured with single electrodes or in loop, sheet, or wire form. The Handpiece Tip is supplied sterile and intended for single patient use. The Handpiece and Cable unit are designed for repeat sterilization by steam autoclave. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The Visage Cosmetic Surgery System is designed for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer's Lactate as an irrigant. Tissue is removed by ablation and hemostasis is performed by coagulation of tissue.
The Visage Cosmetic Surgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
The provided text describes a medical device, the Visage Cosmetic Surgery System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed performance studies with acceptance criteria as one might find for a novel device or a device requiring de novo classification.
Therefore, I cannot fulfill your request for the tables and specific study details. The document explicitly states:
- "The technological characteristics of the Visage Cosmetic Surgery System are the same as those of the ArthroCare Dermal Electrosurgery System, as well as the ArthroCare Arthroscopic Systems and the ConMed Hyfrecator Plus. These devices are equivalent in terms of materials, principle of operation and sterilization."
- "By virtue of design, principle of operation, materials and intended use, we believe the Visage Cosmetic Surgery System is substantially equivalent to devices currently marketed in the United States. We believe that the Visage Cosmetic Surgery System, which is intended for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation does not raise any new issues of safety and/or effectiveness."
This indicates the device's clearance was based on its similarity to existing devices, not on specific performance studies against pre-defined acceptance criteria for this new device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.