(208 days)
The eTwo Skin Treatment system is intended for dermatological procedures.
The Sublative RF applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.
The Sublime applicator is indicated for non invasive wrinkles treatment.
The eTwo skin treatment system is a mobile operating system combining two treatment applicators:
- . Sublative RF applicator, which is intended for dermatological procedures requiring ablation and resurfacing of the skin and for ablation and resurfacing of the skin for wrinkle treatment. Sublative RF's technology enables skin remodeling with minimal downtime. In fractional treatment, small damaged areas are created in the skin, accelerating tissue healing process after treatment.
- Sublime applicator, which is intended for non invasive wrinkles treatment. The applicator uses pulsed infrared light combined with RF energy for Deep Tissue Stimulation leading to skin tightening. Thermal stimulation of the deep dermis contributes to collagen enrichment and tissue remodeling.
The provided document states: "Syneron believes that clinical data is not required to determine the safety and efficacy of the eTwo Skin Treatment System."
Therefore, this device does not have a study proving it meets acceptance criteria, as no clinical performance data was provided.
Consequently, none of the requested information (performance table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set sample size) can be extracted from the provided text.
§ 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.