(14 days)
The LITHO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotnpsy. Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The LITHO Laser System is a surgical laser instrument for use in general surgery and dermatology. The LITHO Laser System includes 1 model. The LITHO laser system is designed with five major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: an Ho:YAG laser rod, capable of generating laser pulses at 2.1um wavelength and a frequency up to 20 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and focusing hand piece; (5) Display and Control Electronics: a display with control electronics, which regulates the functions of the laser and allows parameter selection by the user. In addition to the five subsystems, the LITHO laser system incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch.
The provided document, K091909 for the Quanta System LITHO Laser System, does not contain any performance study data, acceptance criteria for performance, or any details about a study to prove the device meets acceptance criteria.
The document explicitly states under the "Performance Data" section: "None" (Page 4).
This 510(k) submission for the LITHO Laser System relies on substantial equivalence to a predicate device (AllMed System Sphinx Laser System K033437) rather than submitting new performance data. The rationale is that the LITHO Laser System has the "same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the LITHO Laser System and its predicate devices raise no new issues of safety or effectiveness." (Page 4).
Therefore, I cannot provide the requested information as it is not present in 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.