Cleared Traditional

K180306 - Nexy

K180306 is the FDA 510(k) clearance for Nexy by Next Sight Srl. It is a Class 2 Ophthalmic device (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

Submission Details

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.

Device Classification

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 37
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
PANOPTIC
K121405 · Welch Allyn, Inc. · Dec 2012
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · Nidek, Inc. · Apr 2002