Perfecta Delivery System, Refurbished

GUDID 00817495024608

Perfecta Delivery System, Refurbished

Candela Corporation

Dermatological dye laser system
Primary Device ID00817495024608
NIH Device Record Key543252c0-ed12-4c9b-89f6-7192b1d11a4f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerfecta Delivery System, Refurbished
Version Model NumberFIN100984
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
GS100817495024608 [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 Date2023-06-20
Device Publish Date2023-03-24

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