Waterlase Laser Tips - A training kit containing 11 different laser tips - BIOLASE, INC.

Duns Number:152165700

Device Description: A training kit containing 11 different laser tips intended for use with Waterlase laser de A training kit containing 11 different laser tips intended for use with Waterlase laser delivery systems. The tips vary in type, length and core diameter.

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More Product Details

Catalog Number

7000825

Brand Name

Waterlase Laser Tips

Version/Model Number

7000825

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K031140

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

6d1ad3bd-4731-4d6a-8380-4746ac1fbd3a

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOLASE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 155