Cleared Traditional

K163195 - PRIMUS

K163195 is an FDA 510(k) clearance for PRIMUS, manufactured by Carl Zeiss Suzhou Co., Ltd.. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K163195 · Carl Zeiss Suzhou Co., Ltd. · Ophthalmic device
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Jun 2017
Decision
218d
Days
Class 2
Risk

K163195 is an FDA 510(k) clearance for the PRIMUS. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Carl Zeiss Suzhou Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 21, 2017 after a review of 218 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 Suzhou Co., Ltd. devices

FDA 510(k) Submission Details - K163195

510(k) Number K163195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2016
Decision Date June 21, 2017
Days to Decision 218 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
108d slower than avg
Panel avg: 110d · This submission: 218d
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 Consultant

Carl Zeiss Meditec, Inc.
Dong Hua

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 57
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K163195.
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