AMA Optics Amblyometer AMBLYO01

GUDID G506AMBYO010

An ophthalmic device for binocular vision testing. The patient views a two image pairs stacked (Top = right dim image/left bright image; Bottom = right bright image//left dim image) through polarizing glasses of a polarizing system and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined.

AMA Optics, Inc.

Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit Binocular vision test unit

• Primary Device ID: G506AMBYO010
• NIH Device Record Key: 657a2ae9-4b7d-4e71-a61b-d6a1d20ed705
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMA Optics Amblyometer
• Version Model Number: Amblyo-01
• Catalog Number: AMBLYO01
• Company DUNS: 192827462
• Company Name: AMA Optics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G506AMBYO010 [Primary]

FDA Product Code

• HLC: Instrument, Measuring, Stereopsis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-09
• Device Publish Date: 2023-08-01

Devices Manufactured by AMA Optics, Inc.

• G506NC010 - NeuroColor: 2023-10-09 An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured pl
• G506BAM010 - AMA Optics Brightness Acuity Meter: 2023-09-11 A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.
• G506MACDX010 - MacDx: 2023-09-11 MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.
• G506PH010 - AMA Optics Panoramic Pinhole: 2023-09-11 An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic.
• G506PHLC010 - AMA Optics Pinhole Clip: 2023-09-11 A lens chip having an optical lens and a pinhole disc with multiple apertures.
• G506PHLC020 - RAM Panoramic Pinhole Clip: 2023-09-11 A lens clip having an optical lens and a pinhole disc with multiple apertures, each surrounded by an opaque halo.
• G506RAM030 - AMA Optics Retinometer: 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture
• G506RAM040 - AMA Optics Retinometer: 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture