GentleLase 12/15/18 RGD Delivery System W/O DCD

GUDID 00817495022369

Delivery System Assembly

CANDELA CORPORATION

Dermatological laser beam guiding handpiece
Primary Device ID00817495022369
NIH Device Record Key8d520685-830a-4ad8-a06d-8ab1164911a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleLase 12/15/18 RGD Delivery System W/O DCD
Version Model Number7122-00-7547
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
GS100817495022369 [Primary]
GS108174950202363 [Previous]

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 Number5
Public Version Date2021-05-24
Device Publish Date2016-09-23

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