Cleared Traditional

K162067 - VX130 Ophthalmic Diagnostic Device

K162067 is the FDA 510(k) clearance for VX130 Ophthalmic Diagnostic Device by Luneau Sas. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K162067 · Luneau Sas · Ophthalmic device
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Apr 2017
Decision
272d
Days
Class 2
Risk

K162067 is an FDA 510(k) clearance for the VX130 Ophthalmic Diagnostic Device. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Luneau Sas (Prunay Le Gillon, FR). The FDA issued a Cleared decision on April 24, 2017 after a review of 272 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Luneau Sas devices

Submission Details

510(k) Number K162067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 110d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKX Tonometer, Ac-powered

All 23
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K162067.
MiiS Horus Scope DPT 100
K181260 · Medimaging Integrated Solution, Inc (Miis) · Jun 2019
Keeler TonoCare Tonometer
K181143 · Keeler Instruments, Inc. · Feb 2019
Tono Vue Non-Contact Tonometer
K180820 · Crystalvue Medical Corporation · Dec 2018
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · Keeler Instruments, Inc. · Dec 2010
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc. · Dec 2000