Cleared Traditional

K143086 - VX120 Ophthalmic Diagnostic Device
(FDA 510(k) Clearance)

K143086 · Luneau Sas · Ophthalmic

Jun 2015

Decision

217d

Days

Class 2

Risk

K143086 is an FDA 510(k) clearance for the VX120 Ophthalmic Diagnostic Device. This device is classified as 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 June 1, 2015, 217 days after receiving the submission on October 27, 2014.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K143086 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2014
Decision Date	June 01, 2015
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF