Universal IPL 560 nm Expert Filter - LUMENIS LTD.

Duns Number:600166524

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Universal IPL 560 nm Expert Filter

Version/Model Number

Universal IPL 560 nm Expert Filter (Set 4)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K142860

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

7d99e53b-bf1a-4177-a20f-547837eff1e0

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

May 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUMENIS LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 361