(22 days)
When used in traditional, non-fractionated mode for:
Incision, excision, ablation, vaporization of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
YOULASER CO2 laser device has a CO2 laser source emitting at 10600 nm. The beam delivery is enabled through an articulated arm.
Emission is triggered by means of the footswitch or the finger switch available on the scanner.
The provided text is a 510(k) summary for the Quanta System SpA Youlaser CO2 device. This document focuses on the regulatory clearance process for a medical device and describes modifications made to an already cleared device. It details the performance testing related to electrical safety, electromagnetic compatibility, and general laser safety standards.
However, the document does not contain information related to the clinical performance of the device in terms of acceptance criteria for a specific medical condition, a clinical study proving such criteria are met, or details about ground truth establishment, expert adjudication, or AI performance metrics.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.
The document states:
- Performance Standards: "There are no mandatory performance standards for this device."
- Performance Testing: "The subject device underwent performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances: IEC 60601-1:2005 + AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-22:2007 + AMD1:2012, IEC 60825-1: 2014. The subject device passed all the required testing and complicable sections of the above-mentioned standards."
This indicates that the performance testing was engineering-focused (electrical, safety, EMC) rather than clinical efficacy or effectiveness for a specific clinical outcome.
§ 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.