GentleLase LE 12MM Delivery System W/O DCD

GUDID 00817495022291

Delivery System Assembly

CANDELA CORPORATION

Dermatological laser beam guiding handpiece
Primary Device ID00817495022291
NIH Device Record Key3a278439-b179-4d6b-ac9c-2f41fa7ba894
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleLase LE 12MM Delivery System W/O DCD
Version Model Number7122-00-3382
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
GS100817495022291 [Primary]
GS108174950202295 [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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