FDA.reportPublic FDA data

IBEX 2-step LED slit lamp

Primary DI
00869228000427
Brand
IBEX 2-step LED slit lamp
Company
Trevi Technology, Inc.
Model
2L
Device 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.
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
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082031000APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIESAppasamy Associates2008-07-31HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869228000427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869228000427008692280004278692280004270869228000427

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

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
00869228000472IBEX Keratometer MK2018-01-01
00869228000434IBEX Wireless LED Binocular Indirect Ophthalmoscope BIO2018-01-01
00869228000441Applanation TonometerAT2018-01-01
00869228000458IBEX LCD digital acuity chartAC2018-01-01

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