Waterlase Laser Tips - A tip kit containing 2 reusable sapphire tips - BIOLASE, INC.

Duns Number:152165700

Device Description: A tip kit containing 2 reusable sapphire tips intended for use with Waterlase laser delive A tip kit containing 2 reusable sapphire tips intended for use with Waterlase laser delivery systems. The tips have the same core diameter of 600 microns and vary in length.

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More Product Details

Catalog Number

7000800

Brand Name

Waterlase Laser Tips

Version/Model Number

C6

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

a30f4aa3-5f57-4446-9276-532e8fa02188

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