LV applicator - LV Applicator, elos Plus - SYNERON MEDICAL LTD

Duns Number:532685716

Device Description: LV Applicator, elos Plus

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More Product Details

Catalog Number

FG70661

Brand Name

LV applicator

Version/Model Number

FG70661

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

098083b7-0c7b-4442-b74d-d2371975a178

Public Version Date

October 08, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNERON MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 194