(55 days)
The Laser Ix Diode Laser System is intended for delivery of laser light to soft tissue in contact or non contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Laser Ix laser system is generally indicated for incision, excision Vaporization, ablation, hemostatis or coagulation of soft tissue In Ear, Nose and Throat and Oral surgery (Otolaryngology), Dental Procedures, Arthroscopy Gastroenterology, General Surgery, Dermatology Plastic surgery, Podiatry, Urology, Gynecology, Neurosurgery (Peripheral nervous system) Pulmonary surgery and cardiothoracic surgery. The Laser Tx Diode laser system can be used with fiber optic laser delivery devices and photosensitizing agents & chromophores to enhance target tissue effects and photo selective application during surgical procedures. The LaserTx Diode Laser system is indicated for incision, excision, vaporization, hemostatis coagulation, ablation of soft tissue, tumors, strictures, obstructions in body organs including urethra, bladder, prostate, uterus, breast, stomach, colon, abdomen, veins lung, brain, ear, nose throat etc. For additional indications for use please refer to attachment. (Additional Indications, identical to predicated device cleared by FDA under 510K application # K032864)
LaserTx™ - Diode Laser & Delivery System
The provided text is a 510(k) clearance letter for a medical device called the LaserTx™ - Diode Laser & Delivery System. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended uses and indications for the device.
It does not contain information about acceptance criteria, device performance metrics, clinical study design (sample size, data provenance, ground truth establishment, adjudication methods), or multi-reader multi-case comparative effectiveness studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding the study design elements you specified based solely on this document. The document confirms that the device is cleared for marketing based on its substantial equivalence to an existing predicate device, but it does not detail the specific performance validation data for the current 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.