OPTOPOL TECHNOLOGY SP Z O O

Address:Zabia Street 42,Zawiercie Slaskie,PL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Perimeter, Automatic, Ac-Powered (HPT) (6)

Premarket Exempt

Yes

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Automated Projection Perimeter - 05903293141113 Catalog Number : 770-001

Device Description : The PTS 2000 automated projection perimeter is a diagnostic instrument designed The PTS 2000 automated projection perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

Device Class : 1

Duns Number: 522052554

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : Yes

Device Count : 1

Automated Perimeter - 05903293141120 Catalog Number : 760-001

Device Description : The PTS 920 automated perimeter is a diagnostic instrument designed for visual f The PTS 920 automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

Device Class : 1

Duns Number: 522052554

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : Yes

Device Count : 1

Automated Perimeter - 05903293141137 Catalog Number : 760-002

Device Description : The PTS 920BY automated projection perimeter is a diagnostic instrument designed The PTS 920BY automated projection perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

Device Class : 1

Duns Number: 522052554

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : Yes

Device Count : 1

Automated Perimeter - 05903293141144 Catalog Number : 765-003

Device Description : The PTS 925 automated perimeter is a diagnostic instrument designed for visual f The PTS 925 automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

Device Class : 1

Duns Number: 522052554

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : Yes

Device Count : 1

Automated Perimeter - 05903293141151 Catalog Number : 765-001

Device Description : The PTS 925W automated perimeter is a diagnostic instrument designed for visual The PTS 925W automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

Device Class : 1

Duns Number: 522052554

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : Yes

Device Count : 1

Automated Perimeter - 05903293141168 Catalog Number : 765-002

Device Description : The PTS 925BY automated perimeter is a diagnostic instrument designed for visual The PTS 925BY automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

Device Class : 1

Duns Number: 522052554

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : Yes

Device Count : 1

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