(144 days)
The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.
DermaScan™ Surgical Laser Scanner is a microprocessor controlled device that converts a surgical laser device into an advanced aesthetic surgery tool for a variety of cosmetic procedures. The device uses motorized mirrors to deflect a laser beam over a specified area in a uniform and controlled manner. Using a sophisticated interface the user can specify a large number of parameters to achieve a scanning procedure that is tailored to the individual needs of the patient. The scanner then controls the actual tissue ablation process to achieve a uniform removal of tissue over the entire area. An aiming beam is used to outline the treated area
The provided text is a 510(k) Premarket Notification for the DermaScan™ Surgical Laser Scanner. This document does not describe acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it's a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily focusing on device description, intended use, and comparison to existing products. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," indicating that no performance studies were conducted or submitted for this device.
Therefore, I cannot provide the requested information from this document. The sections on acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC studies are not present.
§ 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.