Cleared Traditional

K110986 - OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

K110986 is an FDA 510(k) clearance for OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1, 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 38-day FDA review.

K110986 · Optomed OY · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
38d
Days
Class 2
Risk

K110986 is an FDA 510(k) clearance for the OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1. 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 May 16, 2011 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K110986

510(k) Number K110986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2011
Decision Date May 16, 2011
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K110986.
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K110986 · OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
Download PDF FDA Summary Optomed OY