Epic 10 Diode Laser System - A dental diode laser system intended for a - BIOLASE, INC.

Duns Number:152165700

Device Description: A dental diode laser system intended for a variety of soft-tissue procedures, laser-assist A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories ( power cord, tip holder, protective eyewear). The patient-contacting components of the delivery system require sterilization prior to use.

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More Product Details

Catalog Number

-

Brand Name

Epic 10 Diode Laser System

Version/Model Number

7400042 Refurbished

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

K121286

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

5b1d399b-c99d-4aaf-b068-48e86fd8fc75

Public Version Date

July 29, 2020

Public Version Number

5

DI Record Publish Date

September 15, 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