Cleared Traditional

K121043 - OPTOS OCT/SLO MICROPERIMETER

K121043 is an FDA 510(k) clearance for OPTOS OCT/SLO MICROPERIMETER, manufactured by Optos Plc.. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K121043 · Optos Plc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Feb 2013
Decision
323d
Days
Class 2
Risk

K121043 is an FDA 510(k) clearance for the OPTOS OCT/SLO MICROPERIMETER. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Optos Plc. (Washington, US). The FDA issued a Cleared decision on February 22, 2013 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Optos Plc. devices

FDA 510(k) Submission Details - K121043

510(k) Number K121043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2012
Decision Date February 22, 2013
Days to Decision 323 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
213d slower than avg
Panel avg: 110d · This submission: 323d
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 66
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K121043.
CIRRUS PHOTO
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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
CIRRUS PHOTO
K112184 · Carl Zeiss Meditec, Inc. · Jun 2012
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
K111157 · Carl Zeiss Meditec, Inc. · Jan 2012