Catalog Number

20102-01

Brand Name

LightScalpel

Version/Model Number

LS-20102-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K141658

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

edd39002-bd7b-447e-a02b-bcb9a819ff01

Public Version Date

September 24, 2018

Public Version Number

4

DI Record Publish Date

October 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-