650nm Revlite SI Dye Handpiece, Red - 650nm Revlite SI Dye Handpiece, Red - Cynosure, Inc.

Duns Number:780318028

Device Description: 650nm Revlite SI Dye Handpiece, Red

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More Product Details

Catalog Number

-

Brand Name

650nm Revlite SI Dye Handpiece, Red

Version/Model Number

100-7017-063

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

K103118

Product Code Details

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Device Record Status

Public Device Record Key

dd51b3f0-223a-42b5-980c-fe08122ebf28

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CYNOSURE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 154