Catalog Number

-

Brand Name

PicoSure 532 Delivery System

Version/Model Number

100-7012-532

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

K143105

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

8a5ff8c0-3949-4e34-bacd-ff71a2b385e4

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

July 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-