Cleared Traditional

K251353 - Eyer 2

K251353 is an FDA 510(k) clearance for Eyer 2, manufactured by Phelcom Technologies. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K251353 · Phelcom Technologies · Ophthalmic device
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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

FDA 510(k) Submission Details - K251353

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.

HKI Device Classification - Class 2, Special Controls

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 59
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