Cleared Special

CONTACT LASER & DIAGNOSTIC LENSES

K023221 · Volk Optical, Inc. · Ophthalmic
Oct 2002
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K023221 is an FDA 510(k) clearance for the CONTACT LASER & DIAGNOSTIC LENSES, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Volk Optical, Inc. (Rockville, US). The FDA issued a Cleared decision on October 11, 2002, 14 days after receiving the submission on September 27, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K023221 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2002
Decision Date October 11, 2002
Days to Decision 14 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement

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
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