Focal 44 Sublative iD (200 Pulses)

GUDID 00817495023779

CANDELA CORPORATION

Multi-modality skin surface treatment system
Primary Device ID00817495023779
NIH Device Record Key838a93bb-6c25-4645-913c-749da0a0d432
Commercial Distribution StatusIn Commercial Distribution
Brand NameFocal 44 Sublative iD (200 Pulses)
Version Model NumberAS79354
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
GS100817495023779 [Primary]
GS107290109950679 [Previous]

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 Date2022-09-28
Device Publish Date2022-09-20

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