Cartessa SHEnB Vybe RF Microneedling

Description

CARTESSA SHEnB VYBE RF

Primary FDA-Cleared Indications 

• Electrocoagulation and Hemostasis: All handpieces (Microneedle Array and One Pin Exact) are cleared for general tissue coagulation and bleeding control during dermatologic procedures.
• Percutaneous Treatment of Facial Wrinkles: The Microneedle Array handpiece is specifically indicated for treating facial wrinkles in Skin Types I–V when used at the 1 MHz frequency with power less than 36W.

Aesthetic and Clinical Applications

Clinicians use the Vybe RF system to target a variety of skin concerns by stimulating collagen and elastin production:

• Skin Rejuvenation: Improving overall skin tone, texture, and complexion.
• Skin Tightening: Addressing skin laxity and sagging, particularly on the face, neck, and jawline.
• Scar Reduction: Minimizing the appearance of acne scars and other types of scarring.
• Texture Refinement: Reducing enlarged pores and smoothing uneven skin texture.
• Delicate Areas: Specialized use for sensitive regions including the periorbital area (eyebags and festoons), décolleté, and hands.
• Body Concerns: Improving the appearance of stretch marks.

Handpiece-Specific Functions

• Microneedle Array (36 Pins): Used for broad skin revitalization and wrinkle treatment using both 1 MHz and 2 MHz frequencies.
• One Pin Exact: Designed for high-precision electrocoagulation in localized areas; notably, it is not specifically indicated by the FDA for wrinkle treatment.
• Integrated LED Therapy: Red LED (630nm) is used to promote healing and rejuvenation, while Blue LED (460nm) targets inflammation and acne-related bacteria.
• Dual-Frequency Modalities: The system is an FDA-cleared Class II electrosurgical unit designed for tissue coagulation and hemostasis. It utilizes two distinct frequencies:
• 1 MHz: Indicated for dermatologic procedures and the percutaneous treatment of facial wrinkles in Skin Types I–V.
• 2 MHz: Indicated for more superficial or general tissue coagulation; note that this frequency is often not specifically indicated for wrinkle treatment alone.

Needle Technology:

• Construction: Uses 36 gold-coated, insulated microneedles in a 6×6 array.
• Precision Depth: Depth is adjustable from 0.5mm to 3.5mm in refined 0.1mm increments.
• Dimensions: Each needle has an outer diameter of approximately Ø 0.3mm.

Robotic Precision Delivery (RPD): Unlike hydraulic or manual systems, the ShenB handpiece uses robotic motor controls to smoothly insert needles, minimizing surface trauma and “tearing” for a nearly pain-free experience.

SPECIFICATIONS

Technical Performance

• Laser Type: Radio Frequency – Bipolar
• Frequencies: FDA-cleared for 1 MHz and 2 MHz delivery.
• Maximum Power: Up to 36W at 1 MHz (with a load resistance of 500Ω).
• Needle Configuration: Uses a 36-needle array of gold-coated, insulated microneedles to focus energy deep in the dermis while sparing the skin’s surface.
• Needle Depth: Precisely adjustable from 0.5mm to 3.5mm in fine 0.1mm increments for highly customized treatments.

Delivery & Handpieces

• Robotic Precision Delivery (RPD): A motorized handpiece system that provides smooth, controlled needle insertion to eliminate the “tearing” sensation and significantly reduce patient pain.
• Chevron-Circuit Pattern: An advanced energy distribution circuit that ensures even heat across the treatment area, preventing “hot spots” and increasing safety.
• Dual Handpiece Capability (Vybe RF II):
  • Microneedle Array Handpiece: For standard fractional skin rejuvenation.
  • One Pin Exact Handpiece: A 1 MHz single-needle delivery system for highly targeted electrocoagulation in delicate areas.

Physical & User Interface

• Display: 10.4-inch wide touch LCD screen featuring an intuitive user interface for real-time treatment monitoring.
• Integrated Light Therapy: Built-in Red and Blue LED lights to complement treatments; Red supports healing/rejuvenation, while Blue provides anti-inflammatory and anti-acne benefits.
• Dimensions: Approximately 19″ x 24″ x 45″ (height reaches 55″ when the handpiece pole is attached).
• Control: Operated via a standard power cord (110V) and includes a foot switch for provider convenience.