FSE Pro Series Delivery System 7122-57-9401

GUDID 00817495022529

Delivery System Assembly

CANDELA CORPORATION

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system
Primary Device ID00817495022529
NIH Device Record Keyeef10b78-594b-4372-9a08-9496d8ab1b36
Commercial Distribution StatusIn Commercial Distribution
Brand NameFSE Pro Series Delivery System
Version Model Number7122-57-9401
Catalog Number7122-57-9401
Company DUNS053468385
Company NameCANDELA CORPORATION
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
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS100817495022529 [Primary]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]
GS108174950202523 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-06-23
Device Publish Date2016-10-03

On-Brand Devices [FSE Pro Series Delivery System]

08174950202523Delivery System Assembly
00817495022529Delivery System Assembly

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