FSE PF1 6-18MM Delivery System W/DCD Assembly 7122-57-3956

GUDID 00817495022543

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 ID00817495022543
NIH Device Record Key20748285-0aaa-43de-a6d5-d5767190276b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFSE PF1 6-18MM Delivery System W/DCD Assembly
Version Model Number7122-57-3956
Catalog Number7122-57-3956
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
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS100817495022543 [Primary]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [Previous]
GS108174950202547 [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 PF1 6-18MM Delivery System W/DCD Assembly]

08174950202547Delivery System Assembly
00817495022543Delivery System Assembly

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