Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are 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). HyLight-CO2 The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared 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. Pixel The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing. ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: * Laser skin resurfacing (ablation and/or vaporization) of soft tissue. The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: * Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 & 1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are 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 Alma Hybrid Laser 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 The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system. • Two wavelengths – CO2 and 1570 nm • Articulated arm • Footswitch • Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator)
Summary parsed at:2026-06-01 05:42:19 UTC
