Cleared Traditional

K121993 - SPECTRALIS HRA + OCT AND VARIANTS

K121993 is an FDA 510(k) clearance for SPECTRALIS HRA + OCT AND VARIANTS, manufactured by Heidelberg Engineering GmbH. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K121993 · Heidelberg Engineering GmbH · Ophthalmic device
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Oct 2012
Decision
111d
Days
Class 2
Risk

K121993 is an FDA 510(k) clearance for the SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, .... Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Heidelberg Engineering GmbH (Fairfax, US). The FDA issued a Cleared decision on October 25, 2012 after a review of 111 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 Heidelberg Engineering GmbH devices

FDA 510(k) Submission Details - K121993

510(k) Number K121993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2012
Decision Date October 25, 2012
Days to Decision 111 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 110d · This submission: 111d
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 42
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K121993.
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K083291 · Carl Zeiss Meditec, Inc. · May 2009