Frax 1550

GUDID 05713530000291

Ellipse A/S

Multi-modality skin surface treatment system
Primary Device ID05713530000291
NIH Device Record Keyeede33e3-ee7f-4a85-aa97-bba903e5849f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFrax 1550
Version Model Number9APP7829
Company DUNS305006145
Company NameEllipse A/S
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 Batchtrue
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
GS105713530000291 [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 Date2021-03-24
Device Publish Date2021-03-16

On-Brand Devices [Frax 1550]

057135300002919APP7829
057135300002779APP7829

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