FDA.reportPublic FDA data

Micromed

Primary DI
08033928121184
Brand
Micromed
Company
MICROMED SPA
Model
LED PHOTIC
Device description
LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the EEG recording. The patient’s retina is stimulated with bright light flashes in order to stimulate brain activity changes. These changes can be used to evaluate brain functioning.The stimulation methods, like the photic stimulation, are integral part of the EEG exams.
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211974000LED PHOTIC SystemMicromed S.P.A.2021-09-23GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033928121184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928121184080339281211848033928121184

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic flash generatorA mains electricity (AC-powered), electronic, device that is used to generate an extremely strong flash or series of flashes of bright light that are used as a photostimulation in a parent device, e.g., an electroencephalograph (EEG), an electroretinograph (ERG), or a euthyscope. This device may be known as a flash booster.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
856998166
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033928120910micromedBRAIN QUICK2018-03-21
08033928121207MicromedLED PHOTIC POWER2021-10-25
08033928120880micromedSystemPlus EVOLUTION2018-03-21
08033928120958MicromedBRAIN QUICK SOFTWARE2018-05-21
08033928120828MicromedSD LTM STIM2018-07-02
08033928120736micromedSD LTM 32 EXPRESS2018-03-21
08033928120743micromedBRAIN SPY PLUS2018-03-21
08033928120750micromedSD LTM 64 EXPRESS2018-03-21
08033928120798micromedMORPHEUS2018-03-21
08033928120897MicromedSD LTM 64 PLUS2018-05-21
08033928120903MicromedSD LTM 32 PLUS2018-05-21

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Primary DI, Brand, Company table
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