Catalog Number

-

Brand Name

LightLas 532

Version/Model Number

LC0014(5W)

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K091534

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

1eadc321-4deb-4fa2-8e6a-5d9688a1cab3

Public Version Date

August 14, 2019

Public Version Number

1

DI Record Publish Date

August 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-