Cleared Traditional

K161194 - PLEX Elite 9000 SS-OCT

K161194 is an FDA 510(k) clearance for PLEX Elite 9000 SS-OCT, manufactured by Carl Zeiss Meditec, Inc.. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K161194 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Oct 2016
Decision
182d
Days
Class 2
Risk

K161194 is an FDA 510(k) clearance for the PLEX Elite 9000 SS-OCT. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on October 26, 2016 after a review of 182 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Carl Zeiss Meditec, Inc. devices

FDA 510(k) Submission Details - K161194

510(k) Number K161194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2016
Decision Date October 26, 2016
Days to Decision 182 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
72d slower than avg
Panel avg: 110d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBO Device Classification - Class 2, Special Controls

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
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 - OBO Tomography, Optical Coherence

All 57
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K161194.
iVue
K163475 · Optovue, Inc. · Jun 2017
3D OCT-1 Maestro
K170164 · Topcon Corporation · Mar 2017
EnFocus 2300, EnFocus 4400
K162783 · Bioptigen, Inc. · Dec 2016
3D OCT-1 Maestro
K161509 · Topcon Corporation · Jul 2016
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
K152205 · Heidelberg Engineering GmbH · May 2016
CIRRUS HD-OCT
K150977 · Carl Zeiss Meditec, Inc. · Sep 2015