Cleared Traditional

K150977 - CIRRUS HD-OCT

K150977 is an FDA 510(k) clearance for CIRRUS HD-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 141-day FDA review.

K150977 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Sep 2015
Decision
141d
Days
Class 2
Risk

K150977 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 September 1, 2015 after a review of 141 days - within the typical 510(k) review window.

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 - K150977

510(k) Number K150977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2015
Decision Date September 01, 2015
Days to Decision 141 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
31d slower than avg
Panel avg: 110d · This submission: 141d
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 K150977.
PLEX Elite 9000 SS-OCT
K161194 · Carl Zeiss Meditec, Inc. · Oct 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
RESCAN 700, CALLISTO EYE
K141844 · Carl Zeiss Meditec, AG · Nov 2014
CIRRUS PHOTO
K133217 · Carl Zeiss Meditec, AG · Mar 2014
RS-3000 ADVANCE
K132323 · Nidek Co., Ltd. · Feb 2014