Catalog Number

-

Brand Name

HELIOS III Collimator Handpiece

Version/Model Number

HELIOS III 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

K152856

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

f8a6eab5-ea90-461d-ac5c-fc1b6e5f6ba3

Public Version Date

November 29, 2019

Public Version Number

1

DI Record Publish Date

November 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-