Catalog Number

LS9011-02, LS9011-03, LS9011-04, LS9030-01, LS9030-03

Brand Name

LightScalpel

Version/Model Number

LS-1005

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

K123037,K132661,K141658

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

33d84e6e-8e93-4c85-be1a-abe20a76844b

Public Version Date

August 27, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-