Catalog Number

Sapphire

Brand Name

LightMed

Version/Model Number

SA-108-A2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2022

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

K170073

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

a1c4b488-6952-451e-a3d4-0269a77b88e9

Public Version Date

August 01, 2022

Public Version Number

2

DI Record Publish Date

July 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-