Cleared Traditional

K210051 - OTE MPS 045 Multi-purpose Lens Care Solution (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K210051 · Ote North America, LLC · Ophthalmic device
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May 2021
Decision
138d
Days
Class 2
Risk

K210051 is an FDA 510(k) clearance for the OTE MPS 045 Multi-purpose Lens Care Solution. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Ote North America, LLC (Inwood, US). The FDA issued a Cleared decision on May 26, 2021 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Ote North America, LLC devices

Submission Details

510(k) Number K210051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2021
Decision Date May 26, 2021
Days to Decision 138 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
28d slower than avg
Panel avg: 110d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Foresight Regulatory Strategies, Inc.
Ellen M. Beucler

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.

Clinical Evidence

ClinicalTrials.gov
NCT03278223 Completed Interventional Industry-sponsored

One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System

194
Patients (actual)
11
Sites
Other
Purpose
Double blind
Masking
Condition studied Myopia; Hyperopia
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Frances L Nicklin, Bsc, MCOptom
Sponsor OTE North America (industry)
Started 2017-08-14 → Primary completion 2017-11-17 → Completed 2017-12-20
Primary outcome
Comfort
View full study on ClinicalTrials.gov