Catalog Number

-

Brand Name

Apolomed

Version/Model Number

HS-890A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 05, 2025

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

K191349

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

19350550-f25f-46c5-a99c-6614384c7bc2

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

January 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-