Cleared Traditional

K200516 - OCT-Camera ID 21101A3

K200516 is the FDA 510(k) clearance for OCT-Camera ID 21101A3 by Optomedical Technologies GmbH. It is a Class 2 Ophthalmic device (product code OBO) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K200516 · Optomedical Technologies GmbH · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
184d
Days
Class 2
Risk

K200516 is an FDA 510(k) clearance for the OCT-Camera ID 21101A3. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Optomedical Technologies GmbH (Luebeck, DE). The FDA issued a Cleared decision on September 2, 2020 after a review of 184 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 Optomedical Technologies GmbH devices

Submission Details

510(k) Number K200516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date September 02, 2020
Days to Decision 184 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
74d slower than avg
Panel avg: 110d · This submission: 184d
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 Consultant

Emergo Global Consulting, LLC
Oliver Eikenberg

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBO Tomography, Optical Coherence

All 36
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