Identity
- Trade Name
- IBEX 2-step LED slit lamp FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures in crystal clear detail, enabling anatomical diagnoses to be made for a variety of eye conditions. FDA UDI
- Model / Reference
- 2L FDA UDI
- Description
- IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures in crystal clear detail, enabling anatomical diagnoses to be made for a variety of eye conditions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869228000427 FDA UDI
- 510(k) Number
- K082031 FDA UDI
- FDA Product Code
- HJO FDA UDI
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1850 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: Ophthalmic examination slit lamp
IBEX 2-step LED slit lamp by Trevi Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Trevi Technology
Sources (1)
- FDA UDI 98c1a98d-a508-4710-b0fb-6a649067bf28 35 fields · synced May 30, 2026