Catalog Number

-

Brand Name

Optilite

Version/Model Number

SMA4215C

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K951760

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

1bf11f36-1bf9-4011-b281-31c26840bef1

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-