Catalog Number

-

Brand Name

HELIOS Ⅱ Collimator Handpiece

Version/Model Number

HELIOS Ⅱ Collimator Handpiece

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

-

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

K083203

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

c07466e2-eb0f-46d7-9b32-a65264e5f531

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-