Cleared Traditional

K133217 - CIRRUS PHOTO

K133217 is an FDA 510(k) clearance for CIRRUS PHOTO, manufactured by Carl Zeiss Meditec, AG. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K133217 · Carl Zeiss Meditec, AG · Ophthalmic device
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Mar 2014
Decision
152d
Days
Class 2
Risk

K133217 is an FDA 510(k) clearance for the CIRRUS PHOTO. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on March 19, 2014 after a review of 152 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, AG devices

FDA 510(k) Submission Details - K133217

510(k) Number K133217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2013
Decision Date March 19, 2014
Days to Decision 152 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
42d slower than avg
Panel avg: 110d · This submission: 152d
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 52
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K133217.
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K121622 · Nidek Co., Ltd. · Mar 2013
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
K121993 · Heidelberg Engineering GmbH · Oct 2012