Diode Laser Tips - A single-use non-sterile fiberoptic laser tip - BIOLASE, INC.

Duns Number:152165700

Device Description: A single-use non-sterile fiberoptic laser tip intended for use with Biolase diode laser sy A single-use non-sterile fiberoptic laser tip intended for use with Biolase diode laser systems.

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More Product Details

Catalog Number

7410002

Brand Name

Diode Laser Tips

Version/Model Number

E3-7 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

K121286,K121286

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

2db71ff9-95ad-4f23-a9e5-93e617e40bff

Public Version Date

July 29, 2020

Public Version Number

6

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

00647529002643

Quantity per Package

30

Contains DI Package

00647529000366

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Boc

"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