Catalog Number

87304

Brand Name

TruFocus LIO Premiere

Version/Model Number

TruFocus LIO Premiere, 577

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

K170718

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

9b1c7fd6-01e0-4495-96b0-65d59833eb78

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

March 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-