Cleared Traditional

K202989 - Myopia Master (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202989 · Oculus Optikger?te GmbH · Ophthalmic device
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Jul 2021
Decision
287d
Days
Class 2
Risk

K202989 is an FDA 510(k) clearance for the Myopia Master. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Oculus Optikger?te GmbH (Wetzlar, DE). The FDA issued a Cleared decision on July 14, 2021 after a review of 287 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 Optikger?te GmbH devices

Submission Details

510(k) Number K202989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date July 14, 2021
Days to Decision 287 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
177d slower than avg
Panel avg: 110d · This submission: 287d
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.