VX130 Ophthalmic Diagnostic Device

Q: What is the product code of K162067?

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

FDA 510(k) K162067 · Luneau Sas

Substantially Equivalent

510(k) numberK162067

Submission

Device name: VX130 Ophthalmic Diagnostic Device
Applicant: Luneau Sas
Prunay Le Gillon, FR
Received: July 26, 2016
Decision date: April 24, 2017
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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More from Keeler Instruments, Inc.

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K143086	VX120 Ophthalmic Diagnostic DeviceHKX · Traditional	06/01/2015SE
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K022413	Luneau 3 Mirror LensHJK · Traditional	09/24/2002SE
K851557	AnesthesiometerHJC · Traditional	05/30/1985SE

Questions and answers

When was VX130 Ophthalmic Diagnostic Device cleared by the FDA?

VX130 Ophthalmic Diagnostic Device (K162067) received a 510(k) decision of Substantially Equivalent on April 24, 2017, 272 days after the submission was received.

What is the product code of K162067?

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