Cleared Traditional

K162039 - OptosAdvance 4.0 Software

K162039 is an FDA 510(k) clearance for OptosAdvance 4.0 Software, manufactured by Optos Plc.. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K162039 · Optos Plc. · Ophthalmic device
Download Printable Device Report (PDF)
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Feb 2017
Decision
201d
Days
Class 2
Risk

K162039 is an FDA 510(k) clearance for the OptosAdvance 4.0 Software. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Optos Plc. (Dunfermline, GB). The FDA issued a Cleared decision on February 8, 2017 after a review of 201 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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 Optos Plc. devices

FDA 510(k) Submission Details - K162039

510(k) Number K162039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2016
Decision Date February 08, 2017
Days to Decision 201 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
91d slower than avg
Panel avg: 110d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFJ Device Classification - Class 2, Special Controls

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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

Hogan Lovells US LLP
Randy Prebula

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 - NFJ System, Image Management, Ophthalmic

All 52
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K162039.
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K141922 · Intelligent Retinal Imaging Systems, LLC · Feb 2015