Cleared Traditional

K201325 - Optomed Smartscope M5 with Optomed Smar...

K201325 is the FDA 510(k) clearance for Optomed Smartscope M5 with Optomed Smar... by Optomed Oyj. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K201325 · Optomed Oyj · Ophthalmic device
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Nov 2020
Decision
186d
Days
Class 2
Risk

K201325 is an FDA 510(k) clearance for the Optomed Smartscope M5 with Optomed Smartscope FA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Optomed Oyj (Oulu, FI). The FDA issued a Cleared decision on November 20, 2020 after a review of 186 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.

View all Optomed Oyj devices

Submission Details

510(k) Number K201325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date November 20, 2020
Days to Decision 186 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
76d slower than avg
Panel avg: 110d · This submission: 186d
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 58
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