Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

The Visualase Cooled Laser Applicator System (VCLAS) is a sterile, single-use, saline-cooled laser applicator with MR-compatible properties designed for neurosurgical ablation of intracranial soft tissue including brain tumors, radiation necrosis, and epileptic foci. It serves as an accessory to the Visualase MRI-guided Laser Ablation Systems (V1 and V2) and delivers controlled laser energy through interstitial irradiation or thermal therapy.

The subject device maintains identical laser fiber specifications (200-1000 µm core diameter, 0.37 numerical aperture, 800-1064 nm wavelength, 7.5-30 mm diffusing region) and cooling catheter design (Makrolon material, sterile saline coolant, 1.5-3.2 mm size) compared to predicates. Key changes include removal of DEHP from inlet/outlet ports and pump tubing to meet global material concerns, and addition of a second pump tubing section to enable compatibility with both V1 and V2 systems.

ISO 10993-1 and applicable horizontal standards for biocompatibility; 21 CFR 820.30 compliant design control procedures for design verification and system verification; EtO sterilization with 10-6 sterilization assurance level.

The VCLAS is substantially equivalent because the changes (DEHP removal and dual-system compatibility tubing) do not affect intended use or fundamental technology, do not impact risks, and testing confirms the device performs as intended. The laser fiber, cooling mechanism, and clinical function remain unchanged, and none of the modifications raise new safety or effectiveness questions.