Cleared Special

Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens

K151961 · Volk Optical, Inc. · Ophthalmic
Aug 2015
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K151961 is an FDA 510(k) clearance for the Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Volk Optical, Inc. (Mentor, US). The FDA issued a Cleared decision on August 18, 2015, 33 days after receiving the submission on July 16, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K151961 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

Similar Devices — HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 40
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