Cleared Traditional

K251353 - Eyer 2 (FDA 510(k) Clearance)

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

K251353 · Phelcom Technologies · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
261d
Days
Class 2
Risk

K251353 is an FDA 510(k) clearance for the Eyer 2. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Phelcom Technologies (São Carlos, BR). The FDA issued a Cleared decision on January 16, 2026 after a review of 261 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Phelcom Technologies devices

Submission Details

510(k) Number K251353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2025
Decision Date January 16, 2026
Days to Decision 261 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
151d slower than avg
Panel avg: 110d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 155
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K251353.
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · Remidio Innovative Solutions Private Limited · Dec 2025
Optina-4C (MHRC-C1N)
K250770 · Optina Diagnostics, Inc. · Sep 2025
3nethra neo HD FA
K243600 · Forus Health Pvt.Ltd · Aug 2025
Resolve Fundus Camera
K250683 · Optain Health, Inc. · Apr 2025
Sentinel Camera
K243664 · Ai Optics · Dec 2024
Verily Numetric Retinal Camera
K242508 · Verily Life Sciences, LLC · Dec 2024