GentleMax LE Delivery System W/O DCD

GUDID 00817495022116

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator
Primary Device ID00817495022116
NIH Device Record Keyeef6c650-5e80-4c4b-a427-cc4267fc3b69
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleMax LE Delivery System W/O DCD
Version Model Number0800-00-1081
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
GS100817495022116 [Primary]
GS108174950202110 [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 Number4
Public Version Date2020-06-17
Device Publish Date2016-09-23

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