Diode Laser System Deep Tissue Handpiece - A reusable topical heating device intended for - BIOLASE, INC.

Duns Number:152165700

Device Description: A reusable topical heating device intended for use with Diode Laser Systems in pain therap A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The device is used with disposable protective shields.

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More Product Details

Catalog Number

6400311

Brand Name

Diode Laser System Deep Tissue Handpiece

Version/Model Number

6400311

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

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

6009ed68-b1e5-4f9c-b27a-c6e1204eb73b

Public Version Date

July 29, 2020

Public Version Number

6

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