Cleared Traditional

K201724 - Pentacam AXL Wave

K201724 is the FDA 510(k) clearance for Pentacam AXL Wave by Oculus Optikgerate GmbH. It is a Class 2 Ophthalmic device (product code MXK) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K201724 · Oculus Optikgerate GmbH · Ophthalmic device
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Oct 2020
Decision
120d
Days
Class 2
Risk

K201724 is an FDA 510(k) clearance for the Pentacam AXL Wave. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Oculus Optikgerate GmbH (Wetzlar, DE). The FDA issued a Cleared decision on October 21, 2020 after a review of 120 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K201724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2020
Decision Date October 21, 2020
Days to Decision 120 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
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K201724.
MYAH
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MYAH
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Myopia Master
K202989 · Oculus Optikger?te GmbH · Jul 2021
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K182659 · Sis Ag, Surgical Instrument Systems · Jul 2019
ARGOS
K191051 · Santec Corporation · May 2019
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · Nidek, Inc. · Aug 1999