Profound Matrix, Standard 64 Sublative iD, (100 Pulse)

GUDID 00817495024073

Candela Corporation

Multi-modality skin surface treatment system
Primary Device ID00817495024073
NIH Device Record Key0834a952-87e2-425c-ad7b-1e08aaac7392
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfound Matrix, Standard 64 Sublative iD, (100 Pulse)
Version Model NumberFIN100271
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
GS100817495024073 [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 Date2022-11-01
Device Publish Date2022-10-24

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