Search Results
Found 1 results
510(k) Data Aggregation
K Number
K163257Device Name
VitreOx Anti-fog Solution
Manufacturer
SiO2 Nanotech, LLC
Date Cleared
2017-05-24
(191 days)
Product Code
OCT, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SiO2 Nanotech, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitreOx® is a temporary anti-fog coating and therein defogs devices such as a laparoscopic accessory intended to facilitate intraoperative defogging of the laparoscope lens thereby maintaining visualization of the surgical site.
Device Description
The device, VitreOx®, is a biocompatible, aqueous solution, when used as indicated. In addition, the solution is alcohol-free. It functions in the same manner as the predicate device. The device is intended to be used prior and during minimal invasive surgeries, to prevent fogging of the lens of devices (laparoscope) that provide visualization during the procedure. The device accessory VitreOx®, can be removed from the lens with typical surgical cleaning methods such as scrubbing with soap and water, autoclaving, etc.
It is a sterile, single-use, disposable, long-lasting (beyond average surgery time of 90 minutes) anti-fog solution that can be applied on endoscope and laparoscope lenses, as well as endoscope sheaths. It is effective instantaneously, wet; but is even more lasting if allowed to dry, or applied prior to surgery to lenses.
Ask a Question
Page 1 of 1