Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm). Removal or lightening of unwanted hair with or without adjuvant preparation (1064 nm). Tattoo Removal: Dark ink (blue and black) (1064 nm). Tattoo Removal: light ink (red, sky blue, green) (532 nm). Port wine birthmarks (532 nm). Telangiectasias (532 nm). Spider angioma (532 nm). Cherry angioma (532 nm). Spider nevi (532 nm). Cafe-au-lait birthmarks (532 nm). Solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 nm). Nevus of ota (1064 nm).
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm). Removal or lightening of unwanted hair with or without adjuvant preparation (1064 nm). Tattoo Removal: Dark ink (blue and black) (1064 nm). Tattoo Removal: light ink (red, sky blue, green) (532 nm). Port wine birthmarks (532 nm). Telangiectasias (532 nm). Spider angioma (532 nm). Cherry angioma (532 nm). Spider nevi (532 nm). Cafe-au-lait birthmarks (532 nm). Solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 nm). Nevus of ota (1064 nm).
The Helios III laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd:YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
Summary parsed at:2026-06-01 06:05:20 UTC
