(71 days)
The Spectra-SP Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
The Spectra-SP Laser System consists of a self-contained console, an articulated arm delivery system, a footswitch and a pair of goggles. The Spectra-SP Laser produces a beam of coherent infrared (10.6μm) and has dual operation mode. (Continuous Wave & Char-Free)
The main console is the heart of the Spectra-SP Laser and contains the optical system (with DC-Excited Sealed-off Carbon Dioxide GAS Tube), cooling system, system controller, and power supply. The main console also includes a key switch over the power on and off, an emergency stop push button that de-energizes the system in emergency situations, and the control panel. There are 4 casters in the console base for moving.
The laser beam exits an articulated arm into a handpiece where it is focused by the final focus lens contained in the handpiece to produce a spot size at the final focal plane. The handpiece components, when inserted in the beam delivery system, change the laser beam characteristics.
The provided text is a 510(k) Summary of Safety and Effectiveness for the MAX Engineering Ltd. Spectra-SP Laser System. It outlines device information, predicate devices, device description, and indications for use.
Crucially, the document explicitly states under section 6. "Performance Data": "None presented."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such data is included in this submission. The device received FDA clearance based on substantial equivalence to predicate devices, not on performance data proving it meets specific acceptance criteria in a study.
§ 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.