PerioLase - The PerioLase is a FR Nd:YAG laser producing - MILLENNIUM DENTAL TECHNOLOGIES, INC.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MILLENNIUM DENTAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1