Tono Vue Non-Contact Tonometer

Q: What is the product code of K180820?

The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.

FDA 510(k) K180820 · Crystalvue Medical Corporation

Substantially Equivalent

510(k) numberK180820

Submission

Device name: Tono Vue Non-Contact Tonometer
Applicant: Crystalvue Medical Corporation
Taoyuan City, TW
Received: March 29, 2018
Decision date: December 14, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HKX – Tonometer, Ac-Powered
Device class: Class II (moderate risk)
Regulation: 21 CFR 886.1930
Specialty: Ophthalmic

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K190382	Intraocular Pressure Tonometer EASYTONHKX · Traditional	Company Elamed	12/06/2019SE
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K162067	VX130 Ophthalmic Diagnostic DeviceHKX · Traditional	Luneau Sas	04/24/2017SE
K143086	VX120 Ophthalmic Diagnostic DeviceHKX · Traditional	Luneau Sas	06/01/2015SE
K113066	Corvis STHKX · Traditional	Oculus Optikgerate GmbH	11/08/2012SE
K111710	Full Auto Tonometer Model TX-20HKX · Special	Canon Inc. -Medical Equipment Group	09/20/2011SE
K093298	Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional	Keeler Instruments, Inc.	12/10/2010SE

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Questions and answers

When was Tono Vue Non-Contact Tonometer cleared by the FDA?

Tono Vue Non-Contact Tonometer (K180820) received a 510(k) decision of Substantially Equivalent on December 14, 2018, 260 days after the submission was received.

What is the product code of K180820?

The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.