Cleared Traditional

K163021 - HAAG-STREIT FUNDUS MODULE 300

K163021 is an FDA 510(k) clearance for HAAG-STREIT FUNDUS MODULE 300, 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 162-day FDA review.

K163021 · Optomed OY · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
162d
Days
Class 2
Risk

K163021 is an FDA 510(k) clearance for the HAAG-STREIT FUNDUS MODULE 300. 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 11, 2017 after a review of 162 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 OY devices

FDA 510(k) Submission Details - K163021

510(k) Number K163021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date April 11, 2017
Days to Decision 162 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 110d · This submission: 162d
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 75
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K163021.
RetiCapture
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Nexy
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Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
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MICROPERIMETER MP-3
K152729 · Nidek Co., Ltd. · Jun 2016
IFUSION
K130656 · Optovue, Inc. · Jul 2013
ICAM FUNDUS CAMERA
K122572 · Optovue, Inc. · Jan 2013