Catalog Number

-

Brand Name

SPECTRALIS

Version/Model Number

SP-PWS-2001A [>20000]

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

K192391

Product Code

MYC

Product Code Name

Ophthalmoscope, Laser, Scanning

Public Device Record Key

f07531fe-f741-42a0-a1c1-ebc6c441d0ce

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-