Motif HR applicator FG70921

GUDID 00817495023694

Motif HR Applicator, elos Plus

Candela Corporation

Multi-modality skin surface treatment system
Primary Device ID00817495023694
NIH Device Record Key03f86802-1072-46d6-84de-75a3622dbb8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMotif HR applicator
Version Model NumberFG70921
Catalog NumberFG70921
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495023694 [Primary]
GS107290109950976 [Previous]

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 Date2023-10-30
Device Publish Date2023-10-20

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