Cleared Traditional

K180378 - Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

K180378 is an FDA 510(k) clearance for Optomed Aurora Camera with Aurora Retin..., 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 52-day FDA review.

K180378 · Optomed OY · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
52d
Days
Class 2
Risk

K180378 is an FDA 510(k) clearance for the Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module. 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 April 5, 2018 after a review of 52 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.

View all Optomed OY devices

FDA 510(k) Submission Details - K180378

510(k) Number K180378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date April 05, 2018
Days to Decision 52 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
58d faster than avg
Panel avg: 110d · This submission: 52d
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.