Search Results

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.

Ask a specific question about this device