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510(k) Data Aggregation
K Number
K170215Device Name
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
Manufacturer
Date Cleared
2017-04-19
(85 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Patient Pocket LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
The LaserDock is a sterile holster accessory to be used with surgical lasers and fiber optic laser energy delivery devices (laser fibers). The LaserDock can be marketed under the following brand names (HolmiumDock, CO2Dock, OmniDock, or KTPDock). During a clinical procedure, when the laser fiber is not deployed in the patient, insertion into the LaserDock provides a sterile and secure holster for temporarily protecting the laser fiber. The sterility of the laser fiber is maintained by the sterile LaserDock.
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.
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