FSE MGL 12/15/18 RGD Delivery System 7122-57-3797

GUDID 00817495022550

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 ID00817495022550
NIH Device Record Key70364dc8-943f-4f93-a57d-60aa0e796b1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFSE MGL 12/15/18 RGD Delivery System
Version Model Number7122-57-3797
Catalog Number7122-57-3797
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
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS100817495022550 [Primary]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [Previous]
GS108174950202554 [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 MGL 12/15/18 RGD Delivery System]

08174950202554Delivery System Assembly
00817495022550Delivery System Assembly

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