Catalog Number

-

Brand Name

LENSAR LLS-fs 3D

Version/Model Number

70-00013-001

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

K143010,K152453,K143010,K152453

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Public Device Record Key

27ec264d-65fe-496c-a06a-7fb6544b9449

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10867744000119

Quantity per Package

1

Contains DI Package

00867744000112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Crate