FDA.reportPublic FDA data

IBEX Wireless LED Binocular Indirect Ophthalmoscope

Primary DI
00869228000434
Brand
IBEX Wireless LED Binocular Indirect Ophthalmoscope
Company
Trevi Technology, Inc.
Model
BIO
Device description
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.
Published
2018-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110205000AAIO-7, AAIO WIRLESSAppasamy Associates2011-02-09HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869228000434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869228000434008692280004348692280004340869228000434

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular ophthalmoscope, line-poweredA mains electricity (AC-powered), ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. It typically consists of a main light to illuminate the interior of the eyeball, a system of lenses and filters and an illuminator beam to eliminate reflexes. Also called a binocular indirect ophthalmoscope (BIO), it produces images that better overcome large refractive errors and subtle colour differences. It can be mounted on a headband or spectacle frames and the power is run through a transformer to reduce this to low-voltage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
614-754-7175info@ibexeye.com

Regulatory Flags#

DUNS number
078605507
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869228000465IBEX Manual RefractorMR2023-01-20
00869228000410IBEX 5-step LED slit lamp5L2018-01-01
00869228000427IBEX 2-step LED slit lamp2L2018-01-01
00869228000472IBEX Keratometer MK2018-01-01
00869228000441Applanation TonometerAT2018-01-01
00869228000458IBEX LCD digital acuity chartAC2018-01-01

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Primary DI, Brand, Company table
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