Catalog Number

-

Brand Name

PicoLO Premium Body

Version/Model Number

PicoLO Premium Body

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

K212573,K212573,K212573

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b9ca0924-63e4-4681-858b-5b0a0e3f07d8

Public Version Date

January 14, 2022

Public Version Number

1

DI Record Publish Date

January 06, 2022

Package DI Number

08800035501402

Quantity per Package

1

Contains DI Package

08800035501303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box