Identity
- Trade Name
- Micromed FDA UDI
- Generic Name
- Ophthalmic flash generator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- LED PHOTIC FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928121184 FDA UDI
- 510(k) Number
- K211974 FDA UDI
- FDA Product Code
- GWE FDA UDI
- GMDN Term
- Ophthalmic flash generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic flash generator
Micromed by Micromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic flash generator.
- Micromed — Micromed, Inc. · Class II
Cleared under the same submission
K211974 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micromed, Inc.
Sources (1)
- FDA UDI 0eb7e058-3f83-44c8-a2c1-41a6e272bb37 34 fields · synced May 30, 2026