Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket. ProFlex CO2 Laser Fibers are packaged in a coiled and tubular, high-density polyethylene (HDPE) carrier providing improved ease of dispensing within the surgical field while maintaining sterility. Coils are contained within non-woven/impermeable polymer, e.g. Tyvek/Mylar, sterile pouches, validated for three-year shelf life, and protected with an outer, nonsterile fiberboard carton. Both sterile pouch and carton are labeled. All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO).
Summary parsed at:2026-06-01 05:42:30 UTC
