Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
NaturaLase CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, urology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.
NaturaLase CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, urology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.
The NaturaLase CO2 Laser System includes a CO2 laser tube, power supply, closed loop cooling system, user interface control, an articulated arm, a scanning hand piece, and a traditional hand piece. The system emits a maximum power of 30 Watt at 10.6 µm. The laser energy is delivered through an articulated arm and with a scanner, distributing the laser energy on the skin in a controlled way with uniform distribution. The scanner design allows the system to ablate small micro spots of tissue, with the ability to deliver micro spots with a size of 120 microns and up to 45 mJ of optical energy per micro spot.
Summary parsed at:2026-06-01 06:05:07 UTC
