(211 days)
The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and displav. an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.
The provided text is related to a 510(k) premarket notification for a medical device called the "Profile 1320 Laser System." This document establishes the substantial equivalence of the device to existing predicate devices based on design, functional features, and intended use.
Based on the provided text, there is no information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. The document focuses on regulatory compliance through substantial equivalence to predicate devices, rather than detailed performance metrics or clinical study results as you would expect for AI/ML device evaluations.
Therefore, I cannot fulfill your request for the specific details outlined (points 1-9) because the necessary information is not present in the provided 510(k) summary. This type of regulatory submission typically does not include the detailed performance study information you are asking for if the device is deemed substantially equivalent to a predicate device.
§ 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.