Search Results
Found 1 results
510(k) Data Aggregation
K Number
K221533Device Name
Plasma Shield
Manufacturer
Date Cleared
2022-09-12
(108 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Plasmatica LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Plasma Shield is to be used prior to and during endoscopic procedures to prevent fogging of the scope lens
Device Description
The Plasma Shield is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. The Plasma Shield device is designed for reducing laparoscopic lens fogging by performing cold plasma treatment of a laparoscope lens. The Plasma Shield device is a cold plasma-based device to be used in an operating room, prior to and during laparoscopic procedures. The cold plasma creates a super hydrophilic scope lens surface after treatment (aka activation). The device does not interact directly with the patient's body.
Ask a Question
Ask a specific question about this device
Page 1 of 1