Cleared Traditional

K253795 - MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

K253795 is an FDA 510(k) clearance for MeniSept 3% Hydrogen Peroxide Cleaning ..., manufactured by Menicon Co, Ltd.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K253795 · Menicon Co, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
258d
Days
Class 2
Risk

K253795 is an FDA 510(k) clearance for the MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on August 13, 2026 after a review of 258 days - an extended review cycle.

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 Menicon Co, Ltd. devices

FDA 510(k) Submission Details - K253795

510(k) Number K253795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date August 13, 2026
Days to Decision 258 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
148d slower than avg
Panel avg: 110d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Andre Vision and Device Research
Bret Andre

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 - LPN Accessories, Soft Lens Products

All 80
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K253795.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · Bausch & Lomb, Incorporated · Dec 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · Chemtex USA, Inc. · Oct 2022
ABT12 multi-purpose solution
K202932 · Bausch & Lomb, Incorporated · May 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · Ote North America, LLC · May 2021
Aqua Naina Sterile Saline Solution
K193441 · Chemtex USA, Inc. · May 2020
PuriLens Plus Preservative Free Saline
K200747 · The Lifestyle Company, Inc. · May 2020