Cleared Traditional

K152311 - Pentacam AXL

K152311 is an FDA 510(k) clearance for Pentacam AXL, manufactured by Oculus Optikgerate GmbH. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K152311 · Oculus Optikgerate GmbH · Ophthalmic device
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Jan 2016
Decision
159d
Days
Class 2
Risk

K152311 is an FDA 510(k) clearance for the Pentacam AXL. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Oculus Optikgerate GmbH (Wetzla, DE). The FDA issued a Cleared decision on January 20, 2016 after a review of 159 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Oculus Optikgerate GmbH devices

FDA 510(k) Submission Details - K152311

510(k) Number K152311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2015
Decision Date January 20, 2016
Days to Decision 159 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
49d slower than avg
Panel avg: 110d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXK Device Classification - Class 2, Special Controls

Product Code MXK Device, Analysis, Anterior Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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

Hogan Lovells US LLP
RANDY PREBULA

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 - MXK Device, Analysis, Anterior Segment

All 14
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K152311.
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ARGOS
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