AMA OPTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004571972	3004571972	AMA OPTICS, INC.	1	N	2026-01-01	1410 Sunset Harbour Dr Ste 208 Miami Beach FL US 33139

Registered Device Listings#

Registration key, Listing key table
Registration key	Listing key
63553	1297806256
63553	1833802528
63553	1038575524
63553	1089229502
63553	1095397746
63553	1160161420
63553	1234435679
63553	1290446812
63553	1368657303
63553	1459271087
63553	1569534358
63553	1819095650
63553	1823153938
63553	1897742009
63553	1900835700

GUDID#

AMA Optics Digital Vision Test - A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.

AMA Optics, Inc.

2023-08-01

AMA Optics Panoramic Pinhole - An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic.

AMA Optics, Inc.

2023-09-01

AMA Optics Lens Holder - An individual ophthalmic lens from a trial lens set. (lens holder)

AMA Optics, Inc.

2023-08-01

AMA Optics Lanyard - A flexible device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., the girth of a patient's waist or thigh, or the length of a leg). It is typically made of oilcloth or pliable steel and marked in units of length (i.e., inches and/or millimeters). It is usually available as a roll which may be encased in a holder. This is a reusable device.

AMA Optics, Inc.

2023-08-01

AMA Optics Cord - A flexible device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., the girth of a patient's waist or thigh, or the length of a leg). It is typically made of oilcloth or pliable steel and marked in units of length (i.e., inches and/or millimeters). It is usually available as a roll which may be encased in a holder. This is a reusable device.

AMA Optics, Inc.

2023-08-01

AMA Optics Cord - A flexible device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., the girth of a patient's waist or thigh, or the length of a leg). It is typically made of oilcloth or pliable steel and marked in units of length (i.e., inches and/or millimeters). It is usually available as a roll which may be encased in a holder. This is a reusable device.

AMA Optics, Inc.

2023-08-01

AMA Optics Cord - A flexible device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., the girth of a patient's waist or thigh, or the length of a leg). It is typically made of oilcloth or pliable steel and marked in units of length (i.e., inches and/or millimeters). It is usually available as a roll which may be encased in a holder. This is a reusable device.

AMA Optics, Inc.

2023-08-01

NeuroColor - An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.

AMA Optics, Inc.

2023-09-30

AMA Optics Brightness Acuity Meter - A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.

AMA Optics, Inc.

2023-09-01

MacDx - MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.

AMA Optics, Inc.

2023-09-01

AMA Optics Pinhole Clip - A lens chip having an optical lens and a pinhole disc with multiple apertures.

AMA Optics, Inc.

2023-09-01

RAM Panoramic Pinhole Clip - A lens clip having an optical lens and a pinhole disc with multiple apertures, each surrounded by an opaque halo.

AMA Optics, Inc.

2023-09-01

AMA Optics Retinometer - An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.).

AMA Optics, Inc.

2023-09-01

AMA Optics Retinometer - An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.). The charts are exchangeable.

AMA Optics, Inc.

2023-09-01

AMA Optics ETDRS - An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination. The charts are exchangeable.

AMA Optics, Inc.

2023-09-01

AMA Optics Retinometer - An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.).

AMA Optics, Inc.

2023-09-01

RAM Testing Frames - Frames for holding lenses and occluder used for vision testing.

AMA Optics, Inc.

2023-08-01

AMA Optics Amblyometer - 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.

2023-08-01

AMA Optics Occluder - A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device.

AMA Optics, Inc.

2023-08-01

AMA Optics Vision Adaptor - 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.

2023-08-01

AMA Optics Occluder - A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device.

AMA Optics, Inc.

2023-08-01

AMA Optics Polarizing Filter - Filter that changes the plane of polarization when linearly polarized light traverses an optically active solid or liquid. This device may also be used in ophthalmology.

AMA Optics, Inc.

2023-08-01

AMA Optics Polarizing Filter - Filter that changes the plane of polarization when linearly polarized light traverses an optically active solid or liquid. This device may also be used in ophthalmology.

AMA Optics, Inc.

2023-08-01

AMA Optics Polarizing Glasses - Glasses that change the plane of polarization when linearly polarized light traverses an optically active solid or liquid. This device may also be used in ophthalmology.

AMA Optics, Inc.

2023-08-01

AMA Optics Retinometer - An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.). The chart is exchangeable.

AMA Optics, Inc.

2023-08-01

AMA Optics Eye Chart - An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination.

AMA Optics, Inc.

2023-08-01

AMA Optics Eye Chart - An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination.

AMA Optics, Inc.

2023-08-01

AMA Optics Eye Chart - An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination.

AMA Optics, Inc.

2023-08-01

AMA Optics Eye Chart - An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination.

AMA Optics, Inc.

2023-08-01

AMA Optics Eye Chart - An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination.

AMA Optics, Inc.

2023-08-01