Identity
- Trade Name
- Gold Lens FDA UDI
- Generic Name
- Electroretinograph electrode FDA UDI
- Device Name
- Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG). FDA UDI
- Model / Reference
- D102 FDA UDI
- Description
- Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG). FDA UDI
Identifiers
- Catalog Number
- D102 FDA UDI
- Primary DI / UDI-DI
- 00855730007337 FDA UDI
- 510(k) Number
- K913239 FDA UDI
- FDA Product Code
- HLZ FDA UDI
- GMDN Term
- Electroretinograph electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1220 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
No
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
No
FDA UDI
Category: Electroretinograph electrode
Gold Lens by Diagnosys Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K913239 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 |
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Manufacturer
- Manufacturer
- Diagnosys Llc
Sources (1)
- FDA UDI f23d4a10-5f77-4c7f-acf0-c2359228dd59 35 fields · synced May 30, 2026