(196 days)
The eCO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The eCO2 Laser System consists of a self-contained console, an articulated arm delivery system with scanner handpiece and a footswitch. The eCO2 produces a beam of coherent infrared light (10.6um) and has two operation modes (Static mode and Dynamic Mode). The laser works in medical applications because 10.6um is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. This heating causes instantaneous vaporization of the target tissue.
The eCO2 Laser System utilizes a CO2 RF module to generate a laser beam with a wavelength of 10.6 um and uses a scanner handpiece. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different scan pattern.
The provided text details a 510(k) summary for the Lutronic Corporation eCO2 Laser System. However, it explicitly states:
"Performance Data None presented."
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or any comparative effectiveness studies. The submission indicates that no performance data was included in this particular 510(k) filing.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.