Optical Biometer HBM-1

Primary DI
08800019600787
Brand
Optical Biometer HBM-1
Company
Huvitz Co., Ltd.
Model
HBM-1
Device description
The Optical Biometer HBM-1 is a medical device that optically measures eye components such as:*Axial length*Corneal curvature radii*Corneal cylinder axis*Anterior chamber depth*Central corneal thickness*Crystalline lens thickness*White-to-white*Pupil diameterThe Optical Biometer HBM-1 also measures corneal topography.The Optical Biometer HBM-1 also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019600787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019600787088000196007878800019600787

GMDN Terms#

Term, Definition table
TermDefinition
Optical low coherence reflectometry (OLCR) biometerA mains electricity (AC-powered) ophthalmic device (a biometer) designed to determine the axial dimensions and frontal section of the eye including other biometric parameters/evaluations such as keratometry, white-to-white distance, pupillometry and consequently corneal power based on optical low coherence reflectometry (OLCR), non contact, measurement methods using light markers and digital image processing. It is normally adjustable on a cross stage with an integral chin rest and used to obtain measurements directly from the eye for processing and display via software, e.g., in an attached computer. Patient intraocular lens (IOL) suitability may also be calculated using different formulae.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688154202
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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08800019601074Visual Acuity Chart System HDC-100HDC-1002025-11-19
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08800019600794Huvitz Integrated Image Server HIIS-1HIIS-12025-08-14
08800019600961OCTiX IntraOral ScannerLSO-100Y4XXCL-24-000012024-11-26
00880019600961Lilivis SCAN OPTOMOLSO-100Y4XXCL-24-000012024-11-26
08800019600978Instrument Table CIT-4100CIT-41002024-06-24
08800019600985Instrument Table CIT-4200CIT-42002024-06-24
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08800019600909Lilivis CAD L-CADL-CADLS-1002024-05-27
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08800019600916Digital Refractor HDR-7100PHDR-7100P2023-08-24
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08800019600503Ref-Keratometer ERK-9100ERK-9100ERK-91002023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHTR-1AHTR-1A2023-06-12
08800019600732Digital Chart HDC-9100NHDC-9100NHDC-9100N2023-06-12
08800019600749Digital Chart HDC-9100PFHDC-9100PFHDC-9100PF2023-06-12

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