El.En Electronic Engineering Spa
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). CO2 Handpieces The Helix CO2 handpieces with wavelength of 10600 nm are indicated for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing * laser derm-abrasion * laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Scanning unit The Helix Scanning unit, with wavelength of 10600 nm is indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Helix Scanning unit, with wavelength of 1570 nm, is indicated for: • Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Helix Scanning unit, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. • Two wavelengths – CO2 and 1570 nm • Articulated arm • Footswitch • Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator) Electrical specifications are: 100-230V ~ single phase, 50/60 Hz, Absorbed electric power 1500 VA (max)
Summary parsed at:2026-06-01 05:31:51 UTC
