Cleared Traditional

K180306 - Nexy

K180306 is an FDA 510(k) clearance for Nexy, manufactured by Next Sight Srl. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K180306 · Next Sight Srl · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
126d
Days
Class 2
Risk

K180306 is an FDA 510(k) clearance for the Nexy. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Next Sight Srl (Limena, IT). The FDA issued a Cleared decision on June 8, 2018 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Next Sight Srl devices

FDA 510(k) Submission Details - K180306

510(k) Number K180306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2018
Decision Date June 08, 2018
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 74
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K180306.
LipiScan Dynamic Meibomian Imager
K182506 · Tearscience, Inc. · Dec 2018
RetCam 3
K182263 · Natus Medical Incorporated · Sep 2018
RetiCapture
K173474 · Ilooda Co,., Ltd. · Jul 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K180378 · Optomed OY · Apr 2018
MICROPERIMETER MP-3
K152729 · Nidek Co., Ltd. · Jun 2016
IFUSION
K130656 · Optovue, Inc. · Jul 2013