Vbeam Prima Base Laser System, JP

GUDID 00817495023281

Pulsed Laser

CANDELA CORPORATION

Dermatological dye laser system
Primary Device ID00817495023281
NIH Device Record Key15a39e16-94c1-4419-a580-db83d0dc98a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVbeam Prima Base Laser System, JP
Version Model Number9914-KK-9081
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
GS100817495023281 [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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