Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
RUBY STAR Laser Q-switched 694nm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
RUBY STAR Laser Q-switched 694nm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
RUBY STAR Q-switched laser system emits a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence via 7-Articulated arm. It consists of an articulated arm delivery system terminated in a hand piece, electronic power supply and interface circuitry, optical chamber with laser rod and cavity optics with cooling system, and an LCD color touch screen with foot pedal switch. Laser energy produced is delivered to the tissue by means of an articulated arm. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using a foot switch.
Summary parsed at:2026-06-01 06:11:06 UTC
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K150997 references 1 predicate/reference device
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