OPTOS PUBLIC LIMITED COMPANY

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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

Ophthalmoscope,Laser,Scanning (MYC) (7) Tomography, Optical Coherence (OBO) (2) Ophthalmoscope, Ac-Powered (HLI) (1) Ophthalmoscope, Laser, Scanning (MYC) (1)

Premarket Exempt

Clear

Optos OCT/SLO - 05057056003856 Catalog Number : 000385

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : OBO

Prescription Use : No

Device Count : 1

Panoramic Ophthalmoscope - 05057056010212 Catalog Number : A1021

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

Panoramic Ophthalmoscope - 05057056100210 Catalog Number : A10021

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

Panoramic Opthalmoscope - 05057056100920 Catalog Number : A10092

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC

Prescription Use : No

Device Count : 1

Panoramic Ophthalmoscope - 05057056106007 Catalog Number : A10600

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

OPTOS ADVANCE IMAGE SERVER - 05057056106397 Catalog Number :

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

Panoramic Ophthalmoscope - 05057056106502 Catalog Number : A10650

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

OPTOS ADVANCE IMAGE SERVER - 05057056106885 Catalog Number :

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

OCT Ophthalmoscope - 05057056107004 Catalog Number : A10700

Device Description : The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc.

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

OCT Ophthalmoscope - 05057056107509 Catalog Number : A10750

Device Description : A desktop retinal imaging device that can perform ultra-widefield scanning laser A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography.

Device Class : 2

Duns Number: 346013337

Premarket Exempt : No

Product Code : MYC, OBO

Prescription Use : Yes

Device Count : 1

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