Catalog Number

-

Brand Name

SPECTRALIS

Version/Model Number

Software with HEYEX 2 V6.12_US

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

K182569

Product Code

MYC

Product Code Name

Ophthalmoscope, Laser, Scanning

Public Device Record Key

18a018e4-b5f7-4942-9ae2-7fdd40e1aa3f

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

April 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-