Cleared Traditional

K170527 - Phoenix Clinical ICON

K170527 is an FDA 510(k) clearance for Phoenix Clinical ICON, manufactured by Phoenix Technology Group, Inc. Dba Phoenix Clinical. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K170527 · Phoenix Technology Group, Inc. Dba Phoenix Clinical · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
205d
Days
Class 2
Risk

K170527 is an FDA 510(k) clearance for the Phoenix Clinical ICON. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Phoenix Technology Group, Inc. Dba Phoenix Clinical (Pleasanton, US). The FDA issued a Cleared decision on September 15, 2017 after a review of 205 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.

FDA 510(k) Submission Details - K170527

510(k) Number K170527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2017
Decision Date September 15, 2017
Days to Decision 205 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
95d slower than avg
Panel avg: 110d · This submission: 205d
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 156
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K170527.
RetiCapture
K173474 · Ilooda Co,., Ltd. · Jul 2018
Nexy
K180306 · Next Sight Srl · Jun 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K180378 · Optomed OY · Apr 2018
HAAG-STREIT FUNDUS MODULE 300
K163021 · Optomed OY · Apr 2017
Eyenez Ophthalmic Camera
K161727 · Eyenez, LLC · Oct 2016
MICROPERIMETER MP-3
K152729 · Nidek Co., Ltd. · Jun 2016
K170527 · Phoenix Clinical ICON
Download PDF FDA Summary Phoenix Technology Gr…