TOMEY CORPORATION.

Address:2-11-33 Noritakeshinmachi, Nishi-ku,NAGOYA Aichi,JP

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Filters

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

Refractometer, Ophthalmic (HKO) (3) Topographer, Corneal, Ac-Powered (MMQ) (3) Tonometer, Ac-Powered (HKX) (2) Instrument, Measuring, Lens, Ac-Powered (HLM) (1) Microscope, Specular (NQE) (1)

Premarket Exempt

No Yes

Clear

AUTO REFKERATOMETER - 04582273600218 Catalog Number :

Device Class : 1

Duns Number: 696280002

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : No

Device Count : 1

AUTO REF-TOPOGRAPHER - 04582273600256 Catalog Number :

Device Class : 1

Duns Number: 696280002

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : No

Device Count : 1

NON-CONTACT TONOMETER - 04582273600263 Catalog Number :

Device Class : 2

Duns Number: 696280002

Premarket Exempt : No

Product Code : HKX

Prescription Use : No

Device Count : 1

SPECULAR MICROSCOPE - 04582273603691 Catalog Number :

Device Class : 2

Duns Number: 696280002

Premarket Exempt : No

Product Code : NQE

Prescription Use : No

Device Count : 1

Topographic Modeling System - 04582273603714 Catalog Number :

Device Class : 1

Duns Number: 696280002

Premarket Exempt : Yes

Product Code : MMQ

Prescription Use : No

Device Count : 1

Auto Lensmeter - 04582273604162 Catalog Number :

Device Class : 1

Duns Number: 696280002

Premarket Exempt : Yes

Product Code : HLM

Prescription Use : No

Device Count : 1

NON-CONTACT TONOMETER - 04582273611740 Catalog Number :

Device Description : The NON-CONTACT TONOMETER FT-100 is a tonometer designed using a non-contact mea The NON-CONTACT TONOMETER FT-100 is a tonometer designed using a non-contact measurement system Air puff gently measures the intraocular pressure of the human eye.

Device Class : 2

Duns Number: 696280002

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

AUTO REFKERATOMETER - 04582273611788 Catalog Number :

Device Class : 1

Duns Number: 696280002

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : No

Device Count : 1

TOPOGRAPHIC MODELING SYSTEM - 04582273612099 Catalog Number :

Device Description : 100V

Device Class : 1

Duns Number: 696280002

Premarket Exempt : Yes

Product Code : MMQ

Prescription Use : No

Device Count : 1

TOPOGRAPHIC MODELING SYSTEM - 04582273612129 Catalog Number :

Device Description : with 31 cone

Device Class : 1

Duns Number: 696280002

Premarket Exempt : Yes

Product Code : MMQ

Prescription Use : No

Device Count : 1

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