Cleared Traditional

K261740 - Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)

K261740 is an FDA 510(k) clearance for Adaptive Optics Scanning Laser Ophthalm..., manufactured by Robotrak Technologies Co., Ltd.. The device is a Class 2 Ophthalmic device with product code MYC cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K261740 · Robotrak Technologies Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
153d
Days
Class 2
Risk

K261740 is an FDA 510(k) clearance for the Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV). Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Robotrak Technologies Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on October 27, 2026 after a review of 153 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K261740

510(k) Number K261740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2026
Decision Date October 27, 2026
Days to Decision 153 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
43d slower than avg
Panel avg: 110d · This submission: 153d
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 Peers - MYC Ophthalmoscope, Laser, Scanning

All 23
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K261740.
KOWA FM-600
K261255 · Kowa Company, Ltd. Chofu Factory · Sep 2026
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
K261740 · Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)
Download PDF FDA Summary Robotrak Technologies…