Cleared Traditional

K201325 - Optomed Smartscope M5 with Optomed Smartscope FA

K201325 is an FDA 510(k) clearance for Optomed Smartscope M5 with Optomed Smar..., manufactured by Optomed Oyj. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K201325

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.

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 104
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