Cleared Traditional

VX130 Ophthalmic Diagnostic Device

K162067 · Luneau Sas · Ophthalmic

Apr 2017

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K162067 is an FDA 510(k) clearance for the VX130 Ophthalmic Diagnostic Device, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Luneau Sas (Prunay Le Gillon, FR). The FDA issued a Cleared decision on April 24, 2017, 272 days after receiving the submission on July 26, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K162067 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2016
Decision Date	April 24, 2017
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF