(143 days)
The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are 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), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The Smart CO2 lasers (SmartXide, Smart US20D) are CO2 laser, having a sealed CO2 gas tube as the lasing medium. These are lasers with a wavelength of 10.6 um. Laser activation is by a footswitch. Overall weight of the laser is 30 kg, and the size is 120 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 15A, 50-60 Hz, single phase.
This 510(k) summary for the Smart CO2 (SmartXide, Smart US20D) Laser with DOT scanner does not contain information about acceptance criteria or a study proving the device meets them.
Instead, the submission states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
The basis for clearance is substantial equivalence to a predicate device (Lumenis UltraPulse Encore). The document argues that the Smart CO2 lasers are substantially equivalent because:
"They are both CO2 lasers with a scanning unit as an accessory, for the identical indications for use."
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because they are not present in the provided text.
§ 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.