Cleared Special

K151961 - Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens

K151961 is an FDA 510(k) clearance for Volk Disposable Iridotomy Lens, manufactured by Volk Optical, Inc.. The device is a Class 2 Ophthalmic device with product code HJK cleared through the Special 510(k) pathway after a 33-day FDA review.

K151961 · Volk Optical, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
33d
Days
Class 2
Risk

K151961 is an FDA 510(k) clearance for the Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Volk Optical, Inc. (Mentor, US). The FDA issued a Cleared decision on August 18, 2015 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K151961

510(k) Number K151961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date August 18, 2015
Days to Decision 33 days
Submission Type Special
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
77d faster than avg
Panel avg: 110d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 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 K151961.
RxSight Contact Lens
K201909 · Rxsight, Inc. · Sep 2020
Endocular Viewing Lenses and Silicone Ring
K173944 · Phakos · Oct 2018
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
K151961 · Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
Download PDF FDA Summary Volk Optical, Inc.