ibexeye.comIBEX Manual Refractor - Manual Refractor is an ophthalmic testing device used to measure an individual’s refractive error and determine their eyeglass prescription.
2023-01-20
TREVI TECHNOLOGY
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005771344 | 3005771344 | TREVI TECHNOLOGY | 1 | Y | 2026-01-01 | 2451 Marblevista Blvd Columbus OH US 43204 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00869228000410 | IBEX 5-step LED slit lamp - 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. | 614-754-7175 | info@ibexeye.com |
| 00869228000427 | IBEX 2-step LED slit lamp - 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. | 614-754-7175 | info@ibexeye.com |
| 00869228000434 | IBEX Wireless LED Binocular Indirect Ophthalmoscope - IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high resolution views of the entire fundus and overlying vitreous. Its optical principles and illumination system allows for visualization of the fundus regardless of high ametropia, hazy ocular media or central opacities. | 614-754-7175 | info@ibexeye.com |
| 00869228000441 | Applanation Tonometer - IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea. | 614-754-7175 | info@ibexeye.com |
| 00869228000458 | IBEX LCD digital acuity chart - The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is designed to provide a comprehensive system for measuring visual acuity. | 614-754-7175 | info@ibexeye.com |
| 00869228000465 | IBEX Manual Refractor - Manual Refractor is an ophthalmic testing device used to measure an individual’s refractive error and determine their eyeglass prescription. | 614-754-7175 | info@ibexeye.com |
| 00869228000472 | IBEX Keratometer - IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the extent and axis of astigmatism. | 614-754-7175 | info@ibexeye.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 145333 | 1530622668 | K110205 | AAIO-7, AAIO WIRLESS | HLI | 2011-02-09 |
| 145333 | 1846333807 | K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | HJO | 2008-07-31 |
| 145333 | 1356323456 | K023676 | APPLANATION TONOMETER | HKX | 2003-04-24 |
| 145333 | 1015045024 | ||||
| 145333 | 1066161854 | ||||
| 145333 | 1199035577 | ||||
| 145333 | 1256127282 | ||||
| 145333 | 1381336494 | ||||
| 145333 | 1474165916 | ||||
| 145333 | 1559065039 | ||||
| 145333 | 1561536874 | ||||
| 145333 | 1777923984 | ||||
| 145333 | 1804263431 | ||||
| 145333 | 1893679856 |
Product Codes Associated With Registrations#
GUDID#
IBEX 2-step LED slit lamp - 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.
2018-01-01
IBEX 5-step LED slit lamp - 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.
2018-01-01
IBEX Keratometer - IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the extent and axis of astigmatism.
2018-01-01
Applanation Tonometer - IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.
2018-01-01
IBEX Wireless LED Binocular Indirect Ophthalmoscope - IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high resolution views of the entire fundus and overlying vitreous. Its optical principles and illumination system allows for visualization of the fundus regardless of high ametropia, hazy ocular media or central opacities.
2018-01-01
IBEX LCD digital acuity chart - The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is designed to provide a comprehensive system for measuring visual acuity.
2018-01-01