Corvis STL

FDA UDI

Class II (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name: Corvis STL FDA UDI
Generic Name: Ophthalmic tonometer, battery-operated FDA UDI
Device Name: The Corvis® ST is a non-contact tonometer equipped with an optical Pachymetry function. The Corvis® ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. During the air puff the eye gets illuminated by a 9 mm slit through the apex and a built-in high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera uses a sequence of 140 Scheimpflug images of the cornea which are analyzed by a built-in computer. Intra ocular pressure is determined by the detection of the applanation moments of the cornea. FDA UDI
Model / Reference: 72300 FDA UDI
Description: The Corvis® ST is a non-contact tonometer equipped with an optical Pachymetry function. The Corvis® ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. During the air puff the eye gets illuminated by a 9 mm slit through the apex and a built-in high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera uses a sequence of 140 Scheimpflug images of the cornea which are analyzed by a built-in computer. Intra ocular pressure is determined by the detection of the applanation moments of the cornea. FDA UDI

Identifiers

Primary DI / UDI-DI: 04049584014085 FDA UDI
510(k) Number: K113066 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 14 Kilogram FDA UDI
Height — 520 Millimeter FDA UDI
Depth — 520 Millimeter FDA UDI
Width — 270 Millimeter FDA UDI

Category: Ophthalmic tonometer, battery-operated

Corvis STL by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — 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: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Sources (1)

FDA UDI 42c8b831-8fcf-482b-a101-ecb6aa97f1db 36 fields · synced Jun 6, 2026