(36 days)
The LightScan accessory device is intended to 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 LightScan to any laser will convert the system into an easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. LightScan may be used for a variety of soft tissue ablation, vaporization and coagulation of soft tissue on the skin, including aesthetic laser surgery where layer by layer of micro-ablation is required. LightScan introduces an extra dimension of control for precise tissue removal using lower power than previously thought possible. The LightScan aiming beam makes 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 LightScan while leaving the physician in full control of laser emission at all times.
LightScan is a hand held device that is flexible enough to allow the freedom to choose the area of treatment without being restricted by the laser systems. LightScan will be sued to manipulate and place a pulsed and/or CW laser beam for use in dermatological applications including ablation, vaporization, and coagulation of soft tissue on the Skin.
The provided text is a 510(k) Summary for the Nidek LightScan, a laser accessory. It describes the device's intended use and technological characteristics, and claims substantial equivalence to a predicate device (Sahar Technologies, Inc. SoftScan).
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.
The 510(k) summary focuses on establishing substantial equivalence based on the device's design and intended use being similar to existing cleared devices, rather than presenting a detailed performance study with defined acceptance criteria and statistical analysis.
Therefore, I cannot populate the table or answer the specific questions about studies, sample sizes, experts, or ground truth based on 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.