Diode Laser Tips - A tip kit containing 3 single-use laser tips - BIOLASE, INC.

Duns Number:152165700

Device Description: A tip kit containing 3 single-use laser tips intended for use with Epic S-Series laser sy A tip kit containing 3 single-use laser tips intended for use with Epic S-Series laser systems. The tips have the same core diameter of 400 microns and vary in length.

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More Product Details

Catalog Number

7400053

Brand Name

Diode Laser Tips

Version/Model Number

Surgical EZ Tips

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

Yes

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

K130465

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

d99f9294-f209-43f5-b8bd-ad8ea9b61aff

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

November 17, 2017

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