Catalog Number

-

Brand Name

RxSight Light Delivery Device (LDD)

Version/Model Number

61002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

P160055

Product Code

PZK

Product Code Name

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Public Device Record Key

646cda7e-c886-4ea0-8a5d-f6183fbe346c

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

April 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-