Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD, MegaJOULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector, SMA 906 connector or manufacturer specific connectors and adaptors.
The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD, MegaJOULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector, SMA 906 connector or manufacturer specific connectors and adaptors.
VaporMAX LDD® family of fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are fiber optic surgical laser energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905 or Trimedyne OmniPulse™ MAX, an anodized aluminum extension sleeve or polymer over-nut for accommodating recessed laser ports, fiber/connector strain relief, and a transmitting optical fiber consisting of a low [OH-], fused silica core fiber with fluorine-doped, fused silica cladding, a fluoropolymer secondary cladding and an ethylene tetrafluorethylene copolymer (ETFE, e.g. DuPont Tefzel 210™) protective jacket. The distal tip is laser polished and is disposed within a fused quartz capsule (cap) containing a beam conditioning lens and a prism for redirecting the output at nearly right angles to the fiber longitudinal axis. The dimensional difference between the optical fiber and the distal cap is equalized with a Udel tube covering the distal length of fiber that may be tasked to pass a cystoscope bridge working channel, sized to match the cap diameter and upon which is dispose a green visual indicator of the fiber rotational orientation. The proximal end of the diameter matching tube is terminated within a patent pending control knob for ergonomic rotational control (aiming). Some models of the VaporMAX LDD, those with subscripted "e", where e" indicates "ergonomic") exploit severing the connection between the redirection prism from the transmitting fiber by providing for free rotation of the cap about the fiber, vial the control knob, thereby aiming the fiber output without torquing the transmitting fiber. VaporMAX LDD fibers are packaged as a coil upon a coated fiberboard or dense polymer carrier card that is intended to provide for ease of dispensing within the surgical field while immobilizing the product within the sterile pouch. The working end (distal section) of the fiber is maintained in a straight configuration to avoid "fiber jumping" when rotated in surgery (due to the device's "memory" of being stored in a coil). Carrier cards are sealed within non-woven/impermeable polymer sterile pouches, e.g., Tyvek/paper or Tyvek/Mylar, currently validated by IQ for a three-year shelf life. Sealed sterile pouches are protected by an outer, nonsterile fiberboard carton. Both the sterile pouch and carton are labeled with the product information per FDA labeling requirements. All tissue contacting VaporMAX LDD materials of construction, and any material
Summary parsed at:2026-06-01 05:26:51 UTC
