Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
LaserDock is indicated to hold laser fibers and prevent any unwanted laser emissions from escaping LaserDock. The LaserDock is designed for use with Ho:YAG ("HolmiumDock"), Nd:YAG, CO2 ("CO2Dock", OmniDock), and KTP ("KTPDock") laser systems when laser fibers are deployed.LaserDock is indicated to hold laser fibers and prevent any unwanted laser emissions from escaping LaserDock. The LaserDock is designed for use with Ho:YAG ("HolmiumDock"), Nd:YAG, CO2 ("CO2Dock", OmniDock), and KTP ("KTPDock") laser systems when laser fibers are deployed.The LaserDock is a sterile holster accessory to be used with surgical lasers and fiber optic laser energy delivery devices (laser fibers). The LaserDock is a single use sterile device comprising of an inner medical grade silicone tube, a clamp for securing the laser fiber in place, and a clam shell housing to protect the inner silicone tubing. When not in use, the laser fiber is held securely within the sterile medical grade silicone tubing by a twist clamp. Upon insertion of the laser fiber into the LaserDock, accidental discharging of laser energy is prevented from escaping the LaserDock and injuring or burning users and patients or creating potential fire hazards within the sterile field or outside of the sterile field.
Summary parsed at:2026-06-01 05:59:35 UTC
Laser Dock
K170215 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K170215 as a predicate