Cleared Traditional

K173944 - Endocular Viewing Lenses and Silicone Ring

K173944 is an FDA 510(k) clearance for Endocular Viewing Lenses and Silicone Ring, manufactured by Phakos. The device is a Class 2 Ophthalmic device with product code HJK cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K173944 · Phakos · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
303d
Days
Class 2
Risk

K173944 is an FDA 510(k) clearance for the Endocular Viewing Lenses and Silicone Ring. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Phakos (Montreuil, FR). The FDA issued a Cleared decision on October 25, 2018 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - 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. Elevated predicate reliance profile. 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 - K173944

510(k) Number K173944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date October 25, 2018
Days to Decision 303 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
193d slower than avg
Panel avg: 110d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJK Device Classification - Class 2, Special Controls

Product Code HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
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 Consultant

The OrthoMedix Group, Inc.
J. D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 40
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K173944.
RxSight Contact Lens
K201909 · Rxsight, Inc. · Sep 2020
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K151961 · Volk Optical, Inc. · Aug 2015
Sensor Medical Family of Vitrectomy Lenses and Products
K142715 · Sensor Medical Technology, LLC · Dec 2014
SUPER VIEW DISPOSABLE BIOM LENS SET
K051630 · Insight Instruments, Inc. · Jun 2005
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
K051103 · Haag-Streit USA, Inc. · Jun 2005
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
K050623 · Volk Optical, Inc. · Mar 2005
K173944 · Endocular Viewing Lenses and Silicone Ring
Download PDF FDA Summary Phakos