Vbeam Prima Base Laser System with 1064

GUDID 00817495023304

Pulsed Laser

CANDELA CORPORATION

Dermatological dye laser system
Primary Device ID00817495023304
NIH Device Record Key90ad8194-5d9e-4ca8-b3f4-0b08833505a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVbeam Prima Base Laser System with 1064
Version Model Number9914-KK-9084
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
GS100817495023304 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

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