Profound Matrix, Standard 64 Sublative iD, (400 Pulse)

GUDID 00817495021379

Candela Corporation

Multi-modality skin surface treatment system
Primary Device ID00817495021379
NIH Device Record Keydda222cf-e66d-48a2-ac28-7862f52355bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfound Matrix, Standard 64 Sublative iD, (400 Pulse)
Version Model NumberFIN100273
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495021379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-31
Device Publish Date2022-10-21

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