FSE VPYAG 12/15/18 RGD Delivery System 7122-57-3792

GUDID 00817495022567

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator
Primary Device ID00817495022567
NIH Device Record Keye61df1e5-12dd-45df-a993-d4d7dde0f2fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFSE VPYAG 12/15/18 RGD Delivery System
Version Model Number7122-57-3792
Catalog Number7122-57-3792
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
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS100817495022567 [Primary]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [Previous]
GS108174950202561 [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 Number4
Public Version Date2020-06-23
Device Publish Date2016-10-03

Devices Manufactured by CANDELA CORPORATION

00817495022444 - GentleYAG LE2020-06-23 Pulsed Laser
00817495022451 - Fiber Cable Assembly2020-06-23 Fiber Assembly
00817495022468 - Fiber Cable Assembly2020-06-23 Fiber Assembly
00817495022475 - GL 15MM Fiber Assembly2020-06-23 Fiber Assembly
00817495022482 - GL 12MM Fiber Assembly2020-06-23 Fiber Assembly
00817495022499 - GentleYAG12MM Fiber Assembly2020-06-23 Fiber Assembly
00817495022505 - GLP 12/15/18MM Fiber Assembly2020-06-23 Fiber Assembly
00817495022512 - VPYAG-LE 8MM RGD Fiber Assembly2020-06-23 Delivery System Assembly

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