Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Single Use CO2 Laser Fiber is indicated for the ablation, coagulation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.
Single Use CO2 Laser Fiber is indicated for the ablation, coagulation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.
Single Use CO2 laser fiber is a single use hollow fiber compatible to CO2 laser systems with the following specifications: equipped with F-SMA receptacle connector; equipped with a CO2 laser source, emitting radiation at 10.6 μm wavelength with pulsed and continuous wave (CW) emission mode; able to produce a beam of maximum 300 μm diameter with maximum 30 mrad divergence at the fiber input plane; with a maximum power of 40 W; equipped with an internal compressed air delivery system capable to generate a positive air flow inside the fiber tube.
Summary parsed at:2026-06-01 05:21:40 UTC
ProFlex CO2 Laser Fiber
K243588 references 1 predicate/reference device
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