Search Results

The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 or SMA 905 compatible connectors. In addition cleared lasers with SMA 906 connectors. The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various vascular tumors. MED-Fibers surgical fiber optic delivery device is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

MED-Fibers surgical laser delivery system fibers contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be used with hand pieces. MED-Fibers surgical laser delivery system fibers has no differences in technology and as such does not raise any new questions on safety or efficacy. Various core diameter sizes (200, 272, 365, 550, 600, 800 and 1000 microns) are offered.