FDA.reportPublic FDA data

AMA Optics Vision Adaptor

Primary DI
G506LVA010
Brand
AMA Optics Vision Adaptor
Company
AMA Optics, Inc.
Model
LVA-01
Catalog number
LVA01
Device description
An ophthalmic device (a bar reader) consisting of a magnifying lens intended to magnify the print of reading material and to be used by a patient/person with impaired vision. The device is placed directly onto reading material which is read from above. It can be made of solid glass or plastic material.
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPEAid, Vision, Optical, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPEAid, Vision, Optical, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G506LVA010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying bar readerAn ophthalmic device (a bar reader) consisting of a magnifying lens intended to magnify the print of reading material and to be used by a patient/person with impaired vision. The device is placed directly onto reading material which is read from above. It can be made of solid glass or plastic material.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
192827462
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G506DG010AMA Optics Digital Vision TestDiagnosticGameDG012023-08-01
G506PH010AMA Optics Panoramic PinholePH-01-PHPH012023-09-01
G506HOLDER010AMA Optics Lens HolderLH-01HOLDER012023-08-01
G506LY010AMA Optics LanyardLY-01LY012023-08-01
G506RAM01160AMA Optics CordCACL-CORDRAM01162023-08-01
G506RAM0280 AMA Optics CordCALC-CORDRAM0282023-08-01
G506RAM03160AMA Optics CordCALC-CORDRAM03162023-08-01
G506NC010NeuroColorCOLOR-01NC012023-09-30
G506BAM010AMA Optics Brightness Acuity MeterGLARE-01-DEUCEBAM012023-09-01
G506MACDX010MacDxMACDX-01-PROMACDX012023-09-01
G506PHLC010AMA Optics Pinhole ClipPHC-01-PHPHLC012023-09-01
G506PHLC020RAM Panoramic Pinhole ClipPHC-O1-PPHPHL022023-09-01
G506RAM030AMA Optics RetinometerRAM-03-PRAM032023-09-01
G506RAM040AMA Optics RetinometerRAM-04-PXLRAM042023-09-01
G506RAM050AMA Optics ETDRSRAM ETDRSRAM052023-09-01
G506RAM20AMA Optics RetinometerRAM-01-ORAM022023-09-01
G506FRAME010RAM Testing FramesFrames-01FRAME012023-08-01
G506AMBYO010AMA Optics AmblyometerAmblyo-01AMBLYO012023-08-01
G506CCCLC0AMA Optics OccluderO-CLIPOCCLC2023-08-01
G506OCCLM0AMA Optics OccluderO-MAGNETICOCCLM2023-08-01