Cleared Traditional

K223575 - Phoenix ICON

K223575 is an FDA 510(k) clearance for Phoenix ICON, manufactured by Neolight, LLC. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K223575 · Neolight, LLC · Ophthalmic device
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Sep 2023
Decision
280d
Days
Class 2
Risk

K223575 is an FDA 510(k) clearance for the Phoenix ICON, Phoenix ICON GO. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Neolight, LLC (Pleasanton, US). The FDA issued a Cleared decision on September 6, 2023 after a review of 280 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 Neolight, LLC devices

FDA 510(k) Submission Details - K223575

510(k) Number K223575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2022
Decision Date September 06, 2023
Days to Decision 280 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
170d slower than avg
Panel avg: 110d · This submission: 280d
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
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K223575.
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K221329 · Phelcom Technologies · Feb 2023
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K221111 · Topcon Corporation · Aug 2022