Duns Number:062754457
Device Description: The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations. The laser consists of two interconnected sections: the cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system which includes the Fiberflex fiber and Trueflex handpiece.
Catalog Number
VIII
Brand Name
PerioLase
Version/Model Number
MVP-7
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030290
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
16778ee5-5f40-49d1-b45e-87cf08f0726d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |