Kowa Kt-800

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA KT-800 FDA UDI
Generic Name: Ophthalmic tonometer, battery-operated FDA UDI
Device Name: The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. FDA UDI
Model / Reference: TO8K FDA UDI
Description: The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987646804109 FDA UDI
510(k) Number: K053444 FDA UDI
FDA Product Code: HKX FDA UDI
GMDN Term: Ophthalmic tonometer, battery-operated FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Dimensions & Sizes

Size: Height — 458 Millimeter FDA UDI
Depth — 457 Millimeter FDA UDI
Width — 274 Millimeter FDA UDI
Weight — 18 Kilogram FDA UDI

Category: Ophthalmic tonometer, battery-operated

Kowa Kt-800 by Kowa Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Kowa Co. , Ltd.

Sources (1)

FDA UDI eee1d92a-defe-48cc-881b-e9c889cc3db8 36 fields · synced May 31, 2026