(117 days)
The CALCULASE Holmium Laser System and Accessories are to be used by qualified surgeons in Urological Laser Lithotripsy stone therapy treatment. It is intended to be used in the fragmentation and vaporization of calculi stones in the urinary system (bladder, urethra, and kidney).
Karl Storz CALCULASE Holmium Laser System is a Holmium Y AG Laser system operating at a wavelength of 2080 (2100) nm with impulse energy of 500-1700mJ and pulse frequency of 4-8Hz. The system is suitable for use in noninvasive and invasive Urological Lithotripsy stone therapy procedures.
This document is a 510(k) summary for the Karl Storz CALCULASE Holmium Laser System and Accessories. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results showing device performance against such criteria.
Therefore, I cannot provide the requested information. The document does not describe the acceptance criteria, nor does it detail a study that proves the device meets specific performance criteria. It primarily asserts substantial equivalence based on similar technologies, designs, safety features, and intended uses to predicate devices.
§ 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.