Tono-Pen AVIA®

FDA UDI

Class II (US FDA UDI)

by Reichert Inc.

Identity

Trade Name: Tono-Pen AVIA® FDA UDI
Generic Name: Ophthalmic tonometer, professional FDA UDI
Device Name: Handheld, battery-powered contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected. FDA UDI
Model / Reference: 230650 FDA UDI
Description: Handheld, battery-powered contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected. FDA UDI

Identifiers

Primary DI / UDI-DI: 00812559010108 FDA UDI
510(k) Number: K053430 FDA UDI
FDA Product Code: HKY FDA UDI
GMDN Term: Ophthalmic tonometer, professional 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

Yes

FDA UDI

Category: Ophthalmic tonometer, professional

Tono-Pen AVIA® by Reichert Inc. — 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: Reichert Inc.

Sources (1)

FDA UDI ab378887-d91a-4955-8025-62966a5b483f 35 fields · synced Jun 1, 2026