Medlite C6

GUDID 00841494100209

Medlite C6 220V Laser Assembly

Cynosure, Inc.

Dermatological frequency-doubled solid-state laser system
Primary Device ID00841494100209
NIH Device Record Key51868817-7cf6-4887-a90c-103361727105
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedlite C6
Version Model Number659-0030-1
Company DUNS780318028
Company NameCynosure, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841494100209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Medlite C6]

00841494100209Medlite C6 220V Laser Assembly
00841494100193Medlite C6 115V Laser Assembly

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