FDA.reportPublic FDA data

Visionix

Primary DI
04580606431553
Brand
Visionix
Company
RIGHT MFG. CO., LTD.
Model
MW50D
Catalog number
VSN5700NB
Device description
DIGITAL PHOTO UNIT SET
Published
2023-01-05
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110129000RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTIONRightmedical Products, LLC2011-08-30HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580606431553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580606431553045806064315534580606431553

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination slit lampAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. 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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth387Millimeter
Height678.5Millimeter
Weight14Kilogram
Width350Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
713383495
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04562230698458RightonRetinomax K+ScreeenRDA1152AA2022-12-09
04562230698502RightonRetinomax K+ScreeenRDA1182AA2022-12-09
04562230698557RightonRetinomax K+ScreeenRDA1172AA2022-12-09
04562230698755RightonRetinomax K+ScreeenRDA1152BA2022-12-09
04562230698809RightonRetinomax K+ScreeenRDA1182BA2022-12-09
04562230698854RightonRetinomax K+ScreeenRDA1172BA2022-12-09
04580606430020RightonRetinomax 5RDA2112AA2022-12-09
04580606430075RightonRetinomax 5RDA2142AA2022-12-09
04580606430129RightonRetinomax 5RDA2132AA2022-12-09
04580606430174RightonRetinomax K-plus5RDA2152AA2022-12-09
04580606430228RightonRetinomax K-plus5RDA2182AA2022-12-09
04580606430273RightonRetinomax K-plus5RDA2172AA2022-12-09
04580606430327RightonRetinomax 5RDA2112BA2022-12-09
04580606430372RightonRetinomax 5RDA2142BA2022-12-09
04580606430426RightonRetinomax 5RDA2132BA2022-12-09
04580606430471RightonRetinomax K-plus5RDA2152BA2022-12-09
04580606430525RightonRetinomax K-plus5RDA2182BA2022-12-09
04580606430570RightonRetinomax K-plus5RDA2172BA2022-12-09
04562230696607RightonSpeedy-K2RDA811AB2022-11-30
04562230698298RightonRetinomax ScreeenRDA1112AA2022-11-30

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