Cleared Traditional

K181534 - CIRRUS HD-OCT

K181534 is the FDA 510(k) clearance for CIRRUS HD-OCT by Carl Zeiss Meditec, Inc.. It is a Class 2 Ophthalmic device (product code OBO) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K181534 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Feb 2019
Decision
249d
Days
Class 2
Risk

K181534 is an FDA 510(k) clearance for the CIRRUS HD-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 February 15, 2019 after a review of 249 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

Submission Details

510(k) Number K181534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2018
Decision Date February 15, 2019
Days to Decision 249 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
139d slower than avg
Panel avg: 110d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K181534.
Spectralis HRA+OCT and Variants
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P200TxE
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RESCAN 700, CALLISTO eye
K180229 · Carl Zeiss Meditec, AG · Jan 2019
Spectralis HRA+OCT and variants with High Magnification Module
K182569 · Heidelberg Engineering GmbH · Oct 2018
Spectralis HRA+OCT and variants with OCT Angiography Module
K181594 · Heidelberg Engineering GmbH · Sep 2018