SureLase - Clinicon "SureLase" 30 Watt Laser System, 3-Year - Clinicon Corporation

Duns Number:785275777

Device Description: Clinicon "SureLase" 30 Watt Laser System, 3-Year Warranty

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More Product Details

Catalog Number

-

Brand Name

SureLase

Version/Model Number

4060

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

K121580

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

e4088f4b-2027-4c00-bc4e-ba68fe6f6f7f

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINICON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21