(55 days)
General
SureFlex™ and AccuFlex™ are intended for use in laser-based surgical applications, including but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, abaltion, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
While designed primarily for holmium (Ho:YAG) lasers, SureFlex™ and AccuFlex™ fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.
Not Found
This document is a 510(k) premarket notification FDA clearance letter for a medical device (SureFlex™ and AccuFlex™ Laser Lithotripsy Fibers). It does not contain the acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states that the FDA has reviewed the premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means the device's safety and effectiveness are considered comparable to devices already on the market, rather than requiring a new, independent study to demonstrate specific performance criteria.
Therefore, I cannot provide the requested information from the provided text as it is not present in this type of FDA document.
§ 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.