AMA Optics Vision Adaptor LVA01

GUDID G506LVA010

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.

AMA Optics, Inc.

Magnifying bar reader
Primary Device IDG506LVA010
NIH Device Record Key7285b1eb-0003-4813-85ee-636cdfe1dd80
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMA Optics Vision Adaptor
Version Model NumberLVA-01
Catalog NumberLVA01
Company DUNS192827462
Company NameAMA Optics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG506LVA010 [Primary]

FDA Product Code

HPEAid, Vision, Optical, Battery-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-09
Device Publish Date2023-08-01

Devices Manufactured by AMA Optics, Inc.

G506NC010 - NeuroColor2023-10-09 An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured pl
G506BAM010 - AMA Optics Brightness Acuity Meter2023-09-11 A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.
G506MACDX010 - MacDx2023-09-11 MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.
G506PH010 - AMA Optics Panoramic Pinhole2023-09-11 An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic.
G506PHLC010 - AMA Optics Pinhole Clip2023-09-11 A lens chip having an optical lens and a pinhole disc with multiple apertures.
G506PHLC020 - RAM Panoramic Pinhole Clip2023-09-11 A lens clip having an optical lens and a pinhole disc with multiple apertures, each surrounded by an opaque halo.
G506RAM030 - AMA Optics Retinometer2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture
G506RAM040 - AMA Optics Retinometer2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture

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