Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D

Q: What is the product code of K050623?

The FDA product code is HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 886.1385.

FDA 510(k) K050623 · Volk Optical, Inc.

Substantially Equivalent

510(k) numberK050623

Submission

Device name: Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D
Applicant: Volk Optical, Inc.
Rockville, MD, US
Received: March 10, 2005
Decision date: March 28, 2005
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic
Device class: Class II (moderate risk)
Regulation: 21 CFR 886.1385
Specialty: Ophthalmic

Other 510(k)s with product code HJK

510(k)	Device	Applicant	Decision
K201909	RxSight Contact LensHJK · Traditional	Rxsight, Inc.	09/10/2020SE
K173944	Endocular Viewing Lenses and Silicone RingHJK · Traditional	Phakos	10/25/2018SE
K151961	Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK · Special	Volk Optical, Inc.	08/18/2015SE
K142715	Sensor Medical Family of Vitrectomy Lenses and ProductsHJK · Traditional	Sensor Medical Technology, LLC	12/16/2014SE
K051630	Super View Disposable Biom Lens SetHJK · Traditional	Insight Instruments, Inc.	06/29/2005SE
K051103	Haag-Streit Contact Glasses Stery Cup, AccessoryHJK · Traditional	Haag-Streit USA, Inc.	06/07/2005SE
K033950	Dorc Vitrectomy Lenses, Model 1284 SeriesHJK · Traditional	Dutch Ophthalmic Research Center (D.O.R.C.)	02/20/2004SE
K030054	Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional	Fci Ophthalmics, Inc.	02/26/2003SE
K023221	Contact Laser & Diagnostic LensesHJK · Special	Volk Optical, Inc.	10/11/2002SE
K022413	Luneau 3 Mirror LensHJK · Traditional	Luneau SA	09/24/2002SE

More from Luneau SA

510(k)	Device	Decision
K151961	Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK · Special	08/18/2015SE
K023221	Contact Laser & Diagnostic LensesHJK · Special	10/11/2002SE
K943125	Quadraspheric Fundus LensHJK · Traditional	09/02/1994SE

Questions and answers

When was Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D cleared by the FDA?

Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D (K050623) received a 510(k) decision of Substantially Equivalent on March 28, 2005, 18 days after the submission was received.

What is the product code of K050623?

The FDA product code is HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 886.1385.