Cleared Traditional

K261255 - KOWA FM-600

K261255 is an FDA 510(k) clearance for KOWA FM-600, manufactured by Kowa Company, Ltd. Chofu Factory. The device is a Class 2 Ophthalmic device with product code MYC cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K261255 · Kowa Company, Ltd. Chofu Factory · Ophthalmic device
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Sep 2026
Decision
148d
Days
Class 2
Risk

K261255 is an FDA 510(k) clearance for the KOWA FM-600. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Kowa Company, Ltd. Chofu Factory (Tokyo, JP). The FDA issued a Cleared decision on September 11, 2026 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Kowa Company, Ltd. Chofu Factory devices

FDA 510(k) Submission Details - K261255

510(k) Number K261255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2026
Decision Date September 11, 2026
Days to Decision 148 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
38d slower than avg
Panel avg: 110d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYC Device Classification - Class 2, Special Controls

Product Code MYC Ophthalmoscope, Laser, Scanning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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

Ken Block Consulting Co., Ltd.
Nana Nagashita

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 - MYC Ophthalmoscope, Laser, Scanning

All 22
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K261255.
OcuMet Beacon (OCUB100)
K241931 · Ocusciences, Inc. · Apr 2025
MAIA (AHMACME001)
K243504 · Centervue S.P.A. · Mar 2025
DRSplus
K213705 · Centervue S.P.A. · Dec 2021
EIDON FA, EIDON, EIDON AF, EIDON UWFL
K211328 · Centervue S.P.A. · Aug 2021
DRSplus
K192113 · Centervue S.P.A. · Nov 2019
EIDON FA
K180526 · Centervue S.P.A. · Jul 2018