Trevi Technology, Inc.

Address:2451 Marblevista Blvd,Columbus,OH,43204,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Biomicroscope, Slit-Lamp, Ac-Powered (HJO) (2) Chart, Visual Acuity (HOX) (1) Keratoscope, Ac-Powered (HLQ) (1) Ophthalmoscope, Ac-Powered (HLI) (1) Tonometer, Manual (HKY) (1)

Premarket Exempt

No Yes

Clear

IBEX 5-step LED slit lamp - 00869228000410 Catalog Number :

Device Description : IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a ste 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.

Device Class : 2

Duns Number: 078605507

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

IBEX 2-step LED slit lamp - 00869228000427 Catalog Number :

Device Class : 2

Duns Number: 078605507

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

IBEX Wireless LED Binocular Indirect Ophthalmoscope - 00869228000434 Catalog Number :

Device Description : IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope 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.

Device Class : 2

Duns Number: 078605507

Premarket Exempt : No

Product Code : HLI

Prescription Use : No

Device Count : 1

Applanation Tonometer - 00869228000441 Catalog Number :

Device Description : IBEX Tonometer is used for determining intraocular tension by measuring the pres IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.

Device Class : 2

Duns Number: 078605507

Premarket Exempt : No

Product Code : HKY

Prescription Use : No

Device Count : 1

IBEX LCD digital acuity chart - 00869228000458 Catalog Number :

Device Description : The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity syst 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.

Device Class : 1

Duns Number: 078605507

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : No

Device Count : 1

IBEX Keratometer - 00869228000472 Catalog Number :

Device Description : IBEX Keratometer is used for measuring the curvature of the anterior surface of IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the extent and axis of astigmatism.

Device Class : 1

Duns Number: 078605507

Premarket Exempt : Yes

Product Code : HLQ

Prescription Use : No

Device Count : 1

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