Catalog Number

AACO09032180

Brand Name

HyLight 50 VSS Applicator for US Hybrid System

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 11, 2021

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"

Yes

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

K203441

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

d4f4e0b7-bf6f-4cb4-b320-e4538ac68b02

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-