Micromed

GUDID 08033928121184

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.

MICROMED SPA

Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator Ophthalmic flash generator

• Primary Device ID: 08033928121184
• NIH Device Record Key: 0eb7e058-3f83-44c8-a2c1-41a6e272bb37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micromed
• Version Model Number: LED PHOTIC
• Company DUNS: 856998166
• Company Name: MICROMED SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033928121184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211974

FDA Product Code

• GWE: Stimulator, Photic, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-02
• Device Publish Date: 2021-10-25

On-Brand Devices [Micromed]

• 08033928121207: LED PHOTIC POWER is the power supply adapter included in LED PHOTIC System. LED PHOTIC System i
• 08033928121184: LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the EEG r
• 08033928120910: The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals su