(89 days)
SoftScan will be used to manipulate and place a pulsed and/or CW laser beam for use in Dermatology for treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin.
Adding the SoftScan to any laser will convert the system into a sophisticated easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. SoftScan may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SoftScan introduces an extra dimension of control for precise tissue removal using lower power than previously thought possible. The SoftScan aiming beam mode visually displays the area about to be treated on the tissue. While watching the aiming beam, the physician can change the shapes and sizes he selects to use. The aiming beam outline will change in a concurrently to continuously display the area that is about to be treated.
Filling the area is done using a precise computer control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. Coordinating the laser emission is done by the SoftScan while leaving the physician in full control of laser emission at all times.
SoftScan is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.
This document does not contain the information required to complete the request. The provided text is a 510(k) summary for the SoftScan device, which describes its intended use and technological characteristics, and a letter from the FDA stating that the device is substantially equivalent to existing devices.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details of a study proving device performance against acceptance criteria.
- Information on sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for any studies.
- Information on training set size or ground truth for the training set.
The document mainly focuses on establishing substantial equivalence to predicate devices, rather than presenting detailed performance study results against specific acceptance criteria.
§ 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.