Cleared Traditional

K132186 - OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2

K132186 is an FDA 510(k) clearance for OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSC..., manufactured by Optomed OY. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K132186 · Optomed OY · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
156d
Days
Class 2
Risk

K132186 is an FDA 510(k) clearance for the OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Optomed OY (Oulu, FI). The FDA issued a Cleared decision on December 18, 2013 after a review of 156 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K132186

510(k) Number K132186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date December 18, 2013
Days to Decision 156 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
46d slower than avg
Panel avg: 110d · This submission: 156d
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 146
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K132186.
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
K141481 · Topcon Corporation · Sep 2014
COBRA FUNDUS CAMERA
K132987 · C.S.O. S.R.L. · Jul 2014
KEELER KAPTURE SOFTWARE
K140450 · Keeler Limited · Jun 2014
IFUSION
K130656 · Optovue, Inc. · Jul 2013
TRC-50DX RETINAL CAMERA
K123101 · Topcon Medical Systems, Inc. · Jun 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289 · Topcon Corp. · May 2013
K132186 · OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
Download PDF FDA Summary Optomed OY